MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP2A/PCHAMFBLK FLSLOT REMVHDS2; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Model Number	96-6242
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
I have been notified today that item 966242 lot s0202933 a/p & chamfer cutting block w/removable handle has nail like sharp objects potentially protruding from them.I believe the product arrived at the (b)(4) dc via (b)(4) usa and all 10 were found to be in this condition.The area team leader has isolated the product and removed 8 more that were in stock to the inventory cage awaiting further instruction.
Additional 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.
Event or Problem Description
Additional information received stated that the affected items were new and in packaging and were removed and isolated within the inventory cage.This would mean that for these particular items were not used in surgery.

• Brand Name: SP2A/PCHAMFBLK FLSLOT REMVHDS2
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10301950
• Report Number: 1818910-2020-16378
• Device Sequence Number: 597038
• Product Code: NJL
• UDI-Device Identifier: 10603295247425
• UDI-Public: 10603295247425
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K043223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 96-6242
• Device Catalogue Number: 966242
• Device Lot Number: SO2029233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1