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 Problems Not Applicable (3189); No Code Available (3191)

Event Date 07/31/2020

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

Today, (b)(6) 2020 at (b)(6) hospital, while implanting a size 54 pinnacle sector 2 shell into a right side primary hip patient, the back end of the pinnacle cup inserter handle broke off when struck with a mallet.The handle broke into two clean pieces and all pieces were found.The rep opened up a backup tray with the same handle and the case proceeded without incident.It took the rep two minutes to bring in the backup tray and about 30 more seconds for the circulator to open it.The patient was not harmed as a result of the broken handle.Time of case was extended less than five minutes.No other consequences.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: the instrument associated with this report was not returned, but photos were provided confirming the complaint.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.

• 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: 10401916
• MDR Text Key: 202739529
• Report Number: 1818910-2020-18054
• 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
• Report Date: 07/31/2020

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: SO2037912
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1