MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HARDINGE CEM REST INTRO LONG; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number	963206000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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
Device report from depuy synthes australia reports an event as follows: during a loan kit inspection, it was noticed that half of the handle snapped off.There is no further information available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: half of the handle has snapped off.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.No further information can be obtained as the case was not reported by the customer.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection found the device broken at the pin handle.The observed condition was consistent as an end of life indicator; damage consistent with repeated use and servicing over 25+ years.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test was not performed since it is not applicable to complaint condition.The overall complaint was confirmed as the observed condition of the [hardinge cem rest intro long] would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary:the device associated with this report was not returned to depuy synthes for evaluation, however photos were provided for review.Review of the provided photos confirmed broken handle.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot:the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: HARDINGE CEM REST INTRO LONG
• Common Device Name: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY INTL LTD. 8010379; st anthonys road; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17423436
• Report Number: 1818910-2023-15573
• Device Sequence Number: 12251049
• Product Code: HWR
• UDI-Device Identifier: 10603295246015
• UDI-Public: 10603295246015
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/31/2023

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: 963206000
• Device Lot Number: WHA-80
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 09/06/2023; 09/14/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/29/2023; 09/07/2023; 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/1998
• 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