MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS

Model Number 2217-50-041

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

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

It was reported that the liner impactor has cross threaded on cup impactor.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint; impactor is cross threaded on cup impactor.The impactor tip was able to be disassembled from the impactor.The threads of the impactor tip exhibited deformation (damage) that is not possible with the intended use of the handle.When the damaged impactor was attached to the impactor head, damage to the impactor head internal threads occurred and made disassembly difficult.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.H10 additional narrative: corrected: h3.

Manufacturer Narrative

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: added: d10.Corrected: h3.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PINN STRAIGHT CUP IMPACTOR
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10254665
• MDR Text Key: 198305098
• Report Number: 1818910-2020-15483
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• 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: 06/25/2020

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: 2217-50-041
• Device Catalogue Number: 221750041
• Device Lot Number: NB122043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 08/07/2020
• Supplement Dates FDA Received: 07/13/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1