MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LCS HP 7DEG RT CUT BLK; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number	950501227
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Material Twisted/Bent (2981); Mechanical Jam (2983); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/15/2019
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.Device is an instrument and is not implanted/explanted.(b)(4).
Event or Problem Description
Total knee replacement: during this procedure, a drill pin was inserted into the block, to fix it to the bone.It was found to be slightly bent, resulting in it jamming in the pin slot.It was "cold welded" and unable to be removed.There was a five minute delay to the procedure.Alternate cutting block sourced from another set.No ae to patient.
Additional Manufacturer Narrative
(b)(4).Investigation summary = > examination of the returned devices 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 HP 7DEG RT CUT BLK
• Common Device Name: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8482262
• Report Number: 1818910-2019-89677
• Device Sequence Number: 1783889
• Product Code: NJL
• UDI-Device Identifier: 10603295225324
• UDI-Public: 10603295225324
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2019

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: 950501227
• Device Lot Number: PG0209
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 06/11/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/17/2019; 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR