MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN POLY EXTRACTOR; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number 221750001

Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(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

Stuck.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not received for examination.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Corrected b4 date and added the lot number.

Manufacturer Narrative

Corrected g4 date.

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.H10 additional narrative: corrected: d4 (lot) and h6 (device codes).Product complaint (b)(4).Investigation summary:the instrument associated with this report was not received for examination.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.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: PINN POLY EXTRACTOR
• Type of Device: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9234193
• MDR Text Key: 173228158
• Report Number: 1818910-2019-111826
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295098928
• UDI-Public: 10603295098928
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/23/2019

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: 221750001
• Device Lot Number: J0404
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 10/23/2019; 10/23/2019; 10/30/2019
• Supplement Dates FDA Received: 10/31/2019; 10/31/2019; 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1