MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN POLY IMPACTOR TIP 36MM; HIP INSTRUMENTS : INSERTION DEVICES

Model Number 2217-50-008

Device Problems Loose or Intermittent Connection (1371); Device Slipped (1584); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

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 36mm poly impactor tip was stripped from the plastic part.The orange tip spins on the handle.No further information was available.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the instrument associated with this report was not returned.Depuy-synthes 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.Territory 239 reported that the 36mm poly impactor tip was stripped from the plastic part.The orange tip spins on the handle.No further information was available.No surgical delay.The device associated with this report was not returned.A search of the complaint database found similar reports and the root cause was attributed to heavy use and wear out.However, with no instrument returned and no more information, no root cause can be determined for this specific instrument.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Complaints will be monitored under post market surveillance sep 419.H10 additional narrative:  corrected: h6 (device).

• Brand Name: PINN POLY IMPACTOR TIP 36MM
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10364323
• MDR Text Key: 201603899
• Report Number: 1818910-2020-17531
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295098973
• UDI-Public: 10603295098973
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2217-50-008
• Device Catalogue Number: 221750008
• Device Lot Number: AY1204
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1