MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 THERMOFORMED INFERIOR INSERT; CORAIL KAR INSTRUMENTS : INSTRUMENT CASES

Catalog Number	L20501
Medical Device Problem Codes	Break (1069); Corroded (1131); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # : (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the insert is deteriorating.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, "the pta instrument was received at the central sterilization service, during the traceability process, it was verified that the status of the trays and lid was already deteriorated: lid and broken trays, with holes and glue, oxidized mills".The product was not returned to depuy synthes, however photos were provided for review.See attachment ¿20230825_172421¿, ¿20230825_172406¿, ¿20230825_172359¿, ¿20230825_172240¿, ¿20230825_172234¿, ¿20230825_172228¿, ¿20230825_172222¿, ¿20230825_172215¿ and ¿20230825_172203¿.The photo investigation revealed that the l20501, thermoformed inferior insert was broken and surface had traces of foreign substance, but it is not possible to confirm that the device was rusted based on available evidence.Based on the available evidence, a definitive root cause could not be determined.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection not completed.The overall complaint was confirmed as the observed condition of the l20501, thermoformed inferior insert would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: THERMOFORMED INFERIOR INSERT
• Common Device Name: CORAIL KAR INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17710743
• Report Number: 1818910-2023-18329
• Device Sequence Number: 12449847
• Product Code: FSM
• UDI-Device Identifier: 10603295258643
• UDI-Public: 10603295258643
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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: L20501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown