DEPTH GAUGE FOR SCREWS: Ø2.7/3.5/4.0MM
Received Sep 1, 2016 · Event occurred Aug 15, 2016
Report 0008031020-2016-00436 · MDR key 5922645
Device
Generic name
Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemente
Manufacturer
Stryker GmbhCatalog number
702876
Lot number
00729U
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
DEVICE WAS FOUND DAMAGED DURING ROUTINE INSPECTION. IT IS NOT KNOWN WHEN THE DEVICE WAS DAMAGED, BUT IT LIKELY OCCURRED DURING HANDLING FOR CLEANING/STERILIZATION. THE DEPTH GAUGE IS BROKEN. THE OUTER SHEATH IS INTACT, BUT THE INNER GAUGE IS IN 2 PIECES. THE NARROW TIP OF THE INNER GAUGE APPEARS TO HAVE SHEARED OFF RIGHT AT THE JUNCTION WHERE IT MEETS THE BROADER PART.
Additional Manufacturer Narrative
THE REPORTED INCIDENT THAT A DEPTH GAUGE FOR SCREWS: Ø2.7/3.5/4.0MM WAS ALLEGED OF ISSUE S-18 (INSTRUMENT BREAKAGE IDENTIFIED OUT OF SURGERY) COULD BE CONFIRMED. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THESE ARE SOME OF THE POSSIBLE CAUSES: THE MIXING OF THE DEPTH GAUGE WITH OTHER HEAVIER DEVICES. THE USER DROPPED THE DEPTH GAUGE AND DAMAGED IT. THE IMPROPER USE OF THE INSIDE PART OF THE DEPTH GAUGE FOR SOMETHING OTHER THAN ITS FUNCTION, WHICH DAMAGED THE DEVICE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE DEPTH GAUGE IS BROKEN. THE OUTER SHELL IS INTACT, BUT THE INNER GAUGE IS IN 2 PIECES. THE NARROW TIP OF THE INNER GAUGE IS IN 2 PIECES. THE NARROW TIP OF THE INNER GAUGE APPEARS TO HAVE BROKEN OFF RIGHT AT THE JUNCTION WHERE IT MEETS THE BROADER PART. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.
Description of Event or Problem
DEVICE WAS FOUND DAMAGED DURING ROUTINE INSPECTION. IT IS NOT KNOWN WHEN THE DEVICE WAS DAMAGED, BUT IT LIKELY OCCURRED DURING HANDLING FOR CLEANING/STERILIZATION. THE DEPTH GAUGE IS BROKEN. THE OUTER SHEATH IS INTACT, BUT THE INNER GAUGE IS IN 2 PIECES. THE NARROW TIP OF THE INNER GAUGE APPEARS TO HAVE SHEARED OFF RIGHT AT THE JUNCTION WHERE IT MEETS THE BROADER PART.