SYNMESH 17MM X 22MM 26MM HEIGHT (TI)
Received Apr 26, 2013
Report 3003506883-2013-10134 · MDR key 3079322
Device
Product problems
- Material Discolored
- Inadequacy of Device Shape and/or Size
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SYNMESH HAD A WRONG FOOTPRINT AND COLOR. THE MEASUREMENTS SHOULD HAVE BEEN 17X22X26, BUT ITS FOOTPRINT WAS 22X28X26. THIS REPORT IS FOR FILE (B)(4).
Additional Manufacturer Narrative
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.
Additional Manufacturer Narrative
ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A MANUFACTURING INVESTIGATION AND THE IMPLANT WAS OF A LIGHT GREEN SYNMESH CAGE. THERE WERE NO NOTICEABLE DAMAGES TO THE PART. THERE WERE SLIGHT MARKS OR DISCOLORATION ON THE OUTSIDE DIAMETER OF THE PART CONSISTENT WITH NORMAL HANDLING POST-PRODUCTION. THE DESIGN OF THIS PART FAMILY REQUIRES NO MARKINGS FOR THE PART NUMBER OR LOT NUMBER ON THE PART, AND NONE WERE FOUND ON THIS IMPLANT. THE SPECIFICATIONS USED FOR THE INSPECTION OF THE PART WERE BASED ON THE PART NUMBER REPORTED. THE PART RETURNED DID NOT MATCH THE LENGTH AND WIDTH OF THE TOP LEVEL DRAWING FOR THE PART NUMBER SPECIFIED. THE LOT NUMBER COULD NOT BE INDEPENDENTLY VERIFIED BECAUSE THERE WERE NO LASER MARKINGS ON THIS PART, AND THE PART WAS NOT RETURNED WITH THE ORIGINAL PACKAGING. AN ALTERNATE PART NUMBER COULD NOT BE IDENTIFIED BASED ON THE PHYSICAL CHARACTERISTICS. THE PART CONFIGURATION (LENGTH, WIDTH, HEIGHT, COLOR) DID NOT MATCH ANY PARTS INCLUDED IN THE SYNMESH PRODUCT FAMILY. THIS COMPLAINT IS INDETERMINATE MANUFACTURING STANDPOINT BECAUSE THE SOURCE OF THE PART COULD NOT BE INDEPENDENTLY VERIFIED AND THE PART CONFIGURATION DOES NOT MATCH ANY OF THOSE IN THE SYNMESH FAMILY.
Additional Manufacturer Narrative
SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4). PLACEHOLDER.