MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 LCS FEM A/P RESC GD STD+; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	228734000
Medical Device Problem Codes	Difficult to Remove (1528); Connection Problem (2900); Device-Device Incompatibility (2919); Material Deformation (2976); Naturally Worn (2988)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/01/2019
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
Once the instruments were opened the nurse was asked to check to make sure the drill and rod fit through the central hole, it was found that it did not fit through the std + a/p resection block but did fit through the other sizes.
Additional Manufacturer Narrative
B)(4).Investigation summary = > examination of the returned device(s) confirms the reported event.Product problem has not been identified.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, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS FEM A/P RESC GD STD+
• 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: 8518730
• Report Number: 1818910-2019-90796
• Device Sequence Number: 1303578
• Product Code: HAW
• UDI-Device Identifier: 10603295110095
• UDI-Public: 10603295110095
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/25/2019

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: 228734000
• Device Lot Number: J0606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/05/2019; 06/14/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/10/2019; 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1