MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 PINN STRAIGHT CUP IMPACTOR; IMPACTORS

Catalog Number 221750041

Device Problem Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

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 core shaft did not rotate to release the implant to insert to the patient¿s acetabulum even pressing the release button of the impactor during the surgery on (b)(6) 2018.Then the surgeon took the impactor fitted with the implant and forcibly removed impactor and the implant.Then.The surgeon tried to insert the implants by attaching the implants loosely to the impactor, but the core shaft did not rotate, again.Third attempt had also same result, the core shaft did not rotate.Finally, the fourth attempt, by using the stem with larger size, and attached more loosely to the impactor, then, the surgeon completed to insert the implant to the patient¿s hip joint since the core shaft rotated as intended.No further information was provided by the hospital.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned instrument did not confirm 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN STRAIGHT CUP IMPACTOR
• Type of Device: IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDIC INC, 1818910; . 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDIC INC, 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7403227
• MDR Text Key: 104710589
• Report Number: 1818910-2018-56857
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221750041
• Device Lot Number: NB24686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2013
• 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