MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S/C & MOD CATH TRL 56/28; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	205556000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head trials do not fit onto trial stick.The sizes are not visible on the head trials.These were found after the case so there were no adverse consequences and the patient was not affected.
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.H11 additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
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.Corrected: d4 (primary udi number).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 = > it was reported that the head trials do not fit onto trial stick.The sizes are not visible on the head trials.These were found after the case so there were no adverse consequences and the patient was not affected.¿ the product was returned to j&j medtech orthopaedics for evaluation.¿ visual inspection of the returned device found it was heavily scratched.The allegation of illegible etch was not confirmed as the investigation did not find sufficient evidence to confirm the reported event.¿ the observed condition of the device is suspected to be attributed to an excessive forceful insertion/extraction technique during trialing or using alternative methods for extraction (such as prying or gripping the trial with pliers or clamps to extract) which are not recommended forms of extraction in the surgical technique.No material or manufacturing defects were observed that would have contributed to the material becoming damaged more easily.¿ a dimensional inspection was not performed since it was not applicable to the complaint condition.¿ a functional evaluation was performed using a sample s/c trial handle angled and it revealed the s/c & mod cath trl 56/28 was able to assemble to the handle successfully.The complaint condition was not replicated.The overall complaint was not confirmed as the observed condition of the s/c & mod cath trl 56/28 would have not contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use, 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 j&j medtech orthopaedics 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 = > a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (ae0803) provided is not a valid finished goods lot# h11.

• Brand Name: S/C & MOD CATH TRL 56/28
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20439285
• Report Number: 1818910-2024-21531
• Device Sequence Number: 8183875
• Product Code: HWT
• UDI-Device Identifier: 10603295084730
• UDI-Public: (01)10603295084730(10)AE0803
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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: 205556000
• Device Lot Number: AE0803
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 01/29/2025; 03/03/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/15/2024; 01/30/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2003
• 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