MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SPECIALIST*2 TIB TRAY IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Catalog Number 966387

Device Problems Crack (1135); Material Deformation (2976); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

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 tibia impactor became loose during surgery.Did not break but very loose.Plastic tip of the impactor hangs down.No surgical delay reported.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : examination of the submitted device confirmed the reported event.The returned device is an obsolete item and the investigation did not indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 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.Corrected: h3.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.

• Type of Device: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10087880
• MDR Text Key: 192030891
• Report Number: 1818910-2020-12534
• Device Sequence Number: 1
• Product Code: HWA
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 966387
• Device Lot Number: H0803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 06/29/2020; 06/29/2020
• Supplement Dates FDA Received: 06/24/2020; 06/30/2020; 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1