MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LPS INSERTER EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 298772030

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2019

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 we lost business a lot of business here in town.All instruments have been pulled to re-allocate within our territory.Broken instruments were in designated box at facility labeled as "broken" or were found in sterile wrapped sets that were returned to the office.No patient was affected.No surgery was affected.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Examination of the returned instrument confirmed the reported observation and also found some components missing.The root cause is attributed to misuse and heavy usage.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LPS INSERTER EXTRACTOR
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8841101
• MDR Text Key: 152800542
• Report Number: 1818910-2019-99639
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295159131
• UDI-Public: 10603295159131
• 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
• Report Date: 07/11/2019

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: 298772030
• Device Lot Number: A0211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1