MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 METAGLENE GUIDE PIN DIA 2.5MM; EXTREMITY INSTRUMENTS : PIN GUIDES

Model Number	2307-87-004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	03/10/2020
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
Delta xtend surgery - wanted to place the metaglene positioning plate 2307-87-003 and drill the 2307-87-004 metaglene central guide pin ø 2.5 mm by inserting it through the whole of the plate.But the pin didn't fit through the whole.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.

• Brand Name: METAGLENE GUIDE PIN DIA 2.5MM
• 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: 9882573
• Report Number: 1818910-2020-09285
• Device Sequence Number: 2546292
• Product Code: LXH
• UDI-Device Identifier: 10603295116455
• UDI-Public: 10603295116455
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 03/10/2020

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: 2307-87-004
• Device Catalogue Number: 230787004
• Device Lot Number: 5356507
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 09/17/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 06/11/2020; 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1