MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PIN TRL LNR NEUT 38ODX22.225ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221822038
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw clip was broken in half and no longer holds the screw to the trial.
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).Investigation summary.According to the information received, "the screw clip has broken in half and no longer holds the screw to the trial." the product was not returned to depuy synthes, however photos were provided for review.See 221822038.Jpg.The photo investigation revealed that screw clip of pin trl lnr neut 38odx22.225id was broken.With the available evidence of photo the allegation of will not hold/retain remains unverified.The observed condition was most likely cause by overtightening of the central screw causing the snap ring to broke.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the pin trl lnr neut 38odx22.225id would contribute to the complained device issue.Based on the investigation findings, potential cause can be attributed 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 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that the screw clip has broken in half and no longer holds the screw to the trial.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the pin trl lnr neut 38odx22.225id was found broken from the screw clip.Therefore this condition cause the screw cannot retain the screw with the trail liner.The reported condition can be confirmed.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was most likely cause by overtightening of the central screw causing the snap ring to broke.The overall complaint was confirmed as the observed condition of the pin trl lnr neut 38odx22.225id would contribute to the complained device issue.¿ based on the investigation findings, the potential cause can be attributed 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.
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 that 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.

• Brand Name: PIN TRL LNR NEUT 38ODX22.225ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 17885192
• Report Number: 1818910-2023-20380
• Device Sequence Number: 7551482
• Product Code: HWT
• UDI-Device Identifier: 10603295099628
• UDI-Public: 10603295099628
• 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): 10/06/2023

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: 221822038
• Device Lot Number: AZ025171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 12/12/2023; 12/18/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/17/2023; 12/13/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2013
• 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