MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA HP FEM NOTCH IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Model Number 9505-01-218

Device Problems Break (1069); Material Twisted/Bent (2981); Scratched Material (3020)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2020

Event Type  malfunction  

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.

Event Description

The rubber of the impactor start wearing off and broken pieces causing debris inside the wound.The event occurred on the date of surgery as a very small piece of the femoral impactor got broken during the surgery with no impact to the patient health or life and to that moment the surgeon was not worried about this issue.The day after the cssd department noticed that the material of the femoral impactors started to wear off and making ( dust like residue) and refused to include the 2 pieces to the set to prevent future incidents.Surgery: total knee replacement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the returned device confirmed device scratches, but no breakage.The noted damage is consistent with device wear out from heavy usage and the investigation did not establish a need for corrective action.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Additional information received stating that the major issue occurred after the surgery in 2 days when doctor noticed that the item can't be used anymore.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, d9, h6 (medical device problem code).Removed pe code visual: stripped/worn/twisted/cross threaded.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3, h6 (health effect - impact code, health effect - clinical code).

• Brand Name: SIGMA HP FEM NOTCH IMPACTOR
• Type of Device: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 11149067
• MDR Text Key: 226100236
• Report Number: 1818910-2021-00830
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295225256
• UDI-Public: 10603295225256
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-01-218
• Device Catalogue Number: 950501218
• Device Lot Number: NB99227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1