MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 MODULAR CENT EPI TRIAL SZ1; EXTREMITY INSTRUMENTS : EPIPHYSIS TRIAL

Catalog Number	230720101
Medical Device Problem Codes	Device-Device Incompatibility (2919); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Trial epiphysis is damaged and won¿t connect to trial stem.
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.
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.H11 additional narrative: added: b5 and h6 (device code) corrected: b3 and d4 (expiration date) the expiration date (7/1/2038) in the initial medwatch was reported in error.The device involved was an instrument and does not have an expiration date.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 received: a.Was there any patient harm/consequence related to the event? no b.Was there any surgical delay related to the event? no c.Can you please clarify what do you mean by ¿damaged¿? was it worn, cracked, broken into pieces, bent, stripped, cross threaded or any device interaction.Worn.
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.H11 additional narrative: added: d9 corrected: d4 (primary udi#) 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: trial epiphysis is damaged and won¿t connect to trial stem.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device found sings of worn out at the modular cent epi trial sz1, additionally the device was stripped at the inner threaded area.A functional test could not be performed as the mating devices were not returned.However, the assembly issues could be confirmed due to the observed stripped condition of the device.The observed condition was consistent with a combination of over tightening and heavy usage during assembling or disassembling process.The overall complaint was confirmed as the observed condition of the modular cent epi trial sz1would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to unintended use error, and 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 reported 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 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: MODULAR CENT EPI TRIAL SZ1
• Common Device Name: EXTREMITY INSTRUMENTS : EPIPHYSIS TRIAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19367998
• Report Number: 1818910-2024-11234
• Device Sequence Number: 7618948
• Product Code: HWT
• UDI-Device Identifier: 10603295115717
• UDI-Public: (01)10603295115717(10)5077054
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170748
• 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): 05/21/2024

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: 230720101
• Device Lot Number: 5077054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 07/15/2024; 07/25/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 05/30/2024; 07/16/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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