MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEM LOCATG DEV OUTRIGGER; KNEE INSTRUMENT : ALIGNMENT DEVICES

Model Number 96-6112

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

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

Match issue.It was reported that as the event (b)(4) happened, considering safety, the distributor checked the same lot products, noted the impact product also with the same issue: 966112 could not pass the way through the slot/hole of 966115.There were no adverse consequences to the patient.No additional information could be provided.

Manufacturer Narrative

Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

Manufacturer Narrative

Product complaint #
=
>(b)(4) this product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Type of Device: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10052934
• MDR Text Key: 191268789
• Report Number: 1818910-2020-12053
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 10603295246855
• UDI-Public: 10603295246855
• Combination Product (y/n): N
• PMA/PMN Number: K043223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

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: 96-6112
• Device Catalogue Number: 966112
• Device Lot Number: GM5197201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 07/01/2020; 06/24/2020
• Supplement Dates FDA Received: 07/02/2020; 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1