MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 PROX REAMING GUIDE DIA 12 MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number	2307-74-012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/01/2020
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
It was reported that the head of the proximal reaming guide internal rod broke off during impaction, the proximal reaming guide 12mm was attached to the reaming guide and internal rod when it broke, and the assembly cannot be disassembled.Two of the mating spikes on the locking screwdriver broke during screw insertion.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H6 patient code: no code available (3191) used to capture the prolonged surgery and insufficient information.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received stating that the surgery time was extended.The duration was only a couple of minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the investigation revealed the returned device could not be disassembled from the device assembly.The investigation did not establish a need for corrective action.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: PROX REAMING GUIDE DIA 12 MM
• Common Device Name: EXTREMITY INSTRUMENTS : PIN GUIDES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10540766
• Report Number: 1818910-2020-20197
• Device Sequence Number: 16286714
• Product Code: LXH
• UDI-Device Identifier: 10603295116165
• UDI-Public: 10603295116165
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2020

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 Model Number: 2307-74-012
• Device Catalogue Number: 230774012
• Device Lot Number: 5259390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 09/17/2020; 10/01/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/21/2020; 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1