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

Model Number 2217-50-041

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
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> the device associated with this report was not returned.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 pinnacle cup insertion handle broke during surgery.The strike end, metal piece where the surgeon strikes it with a mallet for impacting a pinnacle cup broke off.Surgeon was able to finish the case, no issues, no delays.There was only 1 broken piece and it was retrieved off the floor.

• 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
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9503536
• MDR Text Key: 184574409
• Report Number: 1818910-2019-124337
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

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 Model Number: 2217-50-041
• Device Catalogue Number: 221750041
• Device Lot Number: SO2029077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 129