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

Catalog Number	950502153
Medical Device Problem Codes	Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Information (3190)
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
It was reported that the size 2 cutting block seemed to take more bone than required for the femur.Patient has healthy bone quality surgeon would like dimensions measured to see if they are correct.
Additional Manufacturer Narrative
Inspection of the returned device was conducted for all critical dimensions found all measured dimensions within specification.A complaint database search finds no additional reported events against the complaint sample product and lot code combination.The investigation did not find any evidence of product malfunction or error.Depuy considers the investigation closed at this time.Should the 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/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6798759
• Report Number: 1818910-2017-22908
• Device Sequence Number: 13845090
• Product Code: NJL
• UDI-Device Identifier: 10603295228523
• UDI-Public: 10603295228523
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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
• Report Date (Section B): 07/18/2017

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: PG0909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1