MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP FBT KEEL PUNCH IMPACT; KNEE INSTRUMENT : HANDLES

Model Number 9505-02-055

Device Problem Device-Device Incompatibility (2919)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 10/26/2020

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

It was reported that the sigma hp tibial prep fbt keel punch and impactor handle disengaged while surgeon attempted to remove keel punch from proximal tibia.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device was unable to replicate the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not established.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Changed device interaction (2+ devices) unable to disassemble to device interaction (2+ devices) will not hold/retain.

• Brand Name: SIGMA HP FBT KEEL PUNCH IMPACT
• Type of Device: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10816254
• MDR Text Key: 215497203
• Report Number: 1818910-2020-24296
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295227717
• UDI-Public: 10603295227717
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9505-02-055
• Device Catalogue Number: 950502055
• Device Lot Number: J1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR