MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG HP FIXED REF AP BLK SZ 2; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	950502153
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Dr (b)(6) - (b)(6) hospital (b)(6) 2018.Surgeon pinned the block insitu, made the femoral cuts but when he went to back the pins out from the block the pin was stuck.Once jnj representative got the pin out of the block in cssd, jnj representative tried to run another pin through the block and it was very difficult to slide a pin through the angled pin hole on the right side of the block.Female patient initial: (b)(6).No delay to procedure.No ae to patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Investigation summary this device was not returned for evaluation but based on the received photographs the complaint can be confirmed.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: SIG HP FIXED REF AP BLK SZ 2
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7442713
• Report Number: 1818910-2018-57777
• Device Sequence Number: 1007245
• Product Code: NJL
• UDI-Device Identifier: 10603295228523
• UDI-Public: 10603295228523
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2018

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 Catalogue Number: 950502153
• Device Lot Number: PG1209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1