MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 GLEN MANUAL REAMER D42 MM; EXTREMITY INSTRUMENTS : REAMERS

Model Number	2307-88-242
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
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 shoulder replacement procedure, during preparation of the glenoid, just prior to using the peripheral reamer, debris was noted on the reamer face.Instrument was not used, scrub nurse handed off the instrument prior to touching the area with the unknown debris, and also changed her gloves.
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.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 was received for examination.Visual examination of the provided photographs confirmed the reported event.The instrument was scratched and a foreign substance was visible on the cutting surface of the reamer.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: GLEN MANUAL REAMER D42 MM
• Common Device Name: EXTREMITY INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 10583161
• Report Number: 1818910-2020-20896
• Device Sequence Number: 572159
• Product Code: HTO
• UDI-Device Identifier: 10603295116486
• UDI-Public: 10603295116486
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 10/08/2020

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: 2307-88-242
• Device Catalogue Number: 230788242
• Device Lot Number: 5070660
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 12/07/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/15/2020; 12/07/2020
• 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