MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PFCSTEINMN PIN/DRIL PAK STERIL; KNEE INSTRUMENT : FIXATION PINS

Catalog Number	864192
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported during a total knee procedure surgeon used the drill from the drill and pin pack to make pilot holes and the drill became lodged in the 7 degree lcs tibial cutting block and broke off in the cutting block.The second drill from the pin pack was used drill the second pilot hole and it also became lodged and broke off in the cutting block.Surgeon believes the diameter of the drill bit was too large for the cutting block.He stated that they seemed tighter than normal.The cutting block with the 2 drill bits will be returned for inspection.
Additional 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.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: PFCSTEINMN PIN/DRIL PAK STERIL
• Common Device Name: KNEE INSTRUMENT : FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7266048
• Report Number: 1818910-2018-53292
• Device Sequence Number: 11261177
• Product Code: HTW
• UDI-Device Identifier: 10603295216476
• UDI-Public: 10603295216476
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2018

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: 864192
• Device Lot Number: HK7505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 02/16/2018; 10/25/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 02/20/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR