MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP IM TIBIA JIG; KNEE INSTRUMENT : ALIGNMENT DEVICES

Catalog Number	950501203
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Locking screws on the hp im jig are sticking.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #: (b)(4).Investigation summary: the product was returned to the engineering dept in australia and assessed.The complainants findings were confirmed and with the product being over 9 years old, the root cause was deemed to be normal wear.Device history lot: null.Device history batch: null.Device history review: null.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).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: HP IM TIBIA JIG
• Common Device Name: KNEE INSTRUMENT : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8631770
• Report Number: 1818910-2019-94265
• Device Sequence Number: 1936149
• Product Code: NJL
• UDI-Device Identifier: 10603295225119
• UDI-Public: 10603295225119
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2019

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: 950501203
• Device Lot Number: A0609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/30/2019; 07/05/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 06/25/2019; 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1