MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 7 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	249256000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
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
During the tibial resection phase of the procedure, a pin broke in two whilst being inserted through the tibial resection block.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device was reviewed by depuy melbourne engineering and failure mode confirmed.Root cause attributed to the device being worn from normal use and servicing.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: TIBIAL RESECTION BLOCK 7 DEG
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8236520
• Report Number: 1818910-2019-80509
• Device Sequence Number: 1624687
• Product Code: HAW
• UDI-Device Identifier: 10603295126003
• UDI-Public: 10603295126003
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 12/16/2018

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: 249256000
• Device Lot Number: AH0596E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2018
• Supplement Date Received by Manufacturer: 01/24/2019; 01/29/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 01/28/2019; 02/04/2019
• Patient Sequence Number: 1
• Patient Age: 74 YR