MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS DISASSEMBLY TOOL; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Model Number 2987-71-000

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 10/29/2020

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 incision and drainage knee with modular component exchange for chronic infection.Remove clamp eyelet broke and needs replaced.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 indicated that the edge of the tip broke in two pieces and were retrieved.

Event Description

Updated the pec from broken intraoperatively to broken intraop: fragment removed from wound.

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

• Brand Name: LPS DISASSEMBLY TOOL
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10830812
• MDR Text Key: 215963989
• Report Number: 1818910-2020-24480
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295159087
• UDI-Public: 10603295159087
• 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
• Report Date: 10/29/2020

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 Model Number: 2987-71-000
• Device Catalogue Number: 298771000
• Device Lot Number: VZ16218
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/17/2020; 12/14/2020
• Supplement Dates FDA Received: 11/18/2020; 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR