SIG HP FBT CEM KL PNCH SZ1.5-3
Received May 9, 2022 · Event occurred Apr 27, 2022
Report 1818910-2022-08447 · MDR key 14336758
Device
Generic name
Knee Instrument : Tibial Keel Punch/bullet
Manufacturer
Depuy Orthopaedics Inc UsModel number
9505-02-047Catalog number
950502047
Lot number
J0709
Product problems
- Device-Device Incompatibility
- Naturally Worn
- Device-Device Incompatibility
- Naturally Worn
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
THE KEEL PUNCH WOULD NOT FIT ONTO THE FBT IMPACTOR. NOTHING BROKE OFF FROM THE INSTRUMENT.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INSTRUMENT STRIPPED. NO SURGICAL DELAY.
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE WAS RECEIVED FOR EXAMINATION, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.
Additional Manufacturer Narrative
PRODUCT COMPLAINT (B)(4). INVESTIGATION SUMMARY: NO DEVICE WAS RECEIVED FOR EXAMINATION. THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. DEPUY CONSIDERS, THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED. AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.