MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PIN TRIAL SHELL 58 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number 221701058

Device Problems Device-Device Incompatibility (2919); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

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 Description

Sales rep reported: the sample cup and the impactor have cold-welded in the thread and can no longer be separated.No patient harm.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: sales rep reported: the sample cup and the impactor have cold-welded in the thread and can no longer be separated.No patient harm.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of returned device found pin trial shell 58 std profile had assembled the tip portion of pinn straight cup impactor.Additionally, nicked and stripped conditions were found on both internal and external surface of device.Where nicked patterns were observed, damage can be consistent with other tools coming in contact with device surface or a component failure that was caused by exposure to unintended forces like usage of excessive force in a prying motion while trialing.The stripped patterns were identified as an end of life indicator; damage consistent with repeated use and servicing over 8 years.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The functional test performed revealed that pin trial shell 58 std profile was unable to disassemble from tip portion of pinn straight cup impactor.Therefore, failing functional test and confirming both jammed and unable to disassemble allegations.Potential cause for these allegations can be traced to failure component as this type of damage comes as a consequence of the weld fracture in tip/insert portion of pinn straight cup impactor.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pin trial shell 58 std profile 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 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/8/2016.3) any anomalies or deviations identified in dhr: n/a.4) expiry date: n/a.5) ifu reference: ifu nonsterile inst rev j.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 12/8/2016.3) any anomalies or deviations identified in dhr: n/a.4) expiry date: n/a.5) ifu reference: ifu nonsterile inst rev j h3.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

1.Was there a surgical delay? if yes, what is the duration of the delay? no.2.Where was this noticed- pre-op /inspection/ surgery? intra op.No patient was harmed.Work was completed with other instruments.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "sales rep reported: the sample cup and the impactor have cold-welded in the thread and can no longer be separated.No patient harm".The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that pin trial shell 58 std profile had assembled, what appears to be, the tip portion of pinn straight cup impactor.Additionally, wear patterns were observed on both internal and external surface of device due to repeated use, confirming allegation.However, with information provided, jammed and unable to disassembled condition cannot be confirmed.The wear condition was identified as an end of life indicator; damage consistent with repeated use and servicing over 8 years.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Since the device was not returned, both dimensional inspection and a functional test cannot be performed.The overall complaint was confirmed as the observed condition of the pin trial shell 58 std profile 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 : 1) quantity manufactured: (b)(4).2) date of manufacture: 12/8/2016.3) any anomalies or deviations identified in dhr: n/a.4) expiry date: n/a.5) ifu reference: ifu nonsterile inst rev j.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "sales rep reported: the sample cup and the impactor have cold-welded in the thread and can no longer be separated.No patient harm".The product was not returned to depuy synthes, however photos were provided for review.(b)(4).The photo investigation revealed that pin trial shell 58 std profile had assembled, what appears to be, the tip portion of pinn straight cup impactor.Additionally, wear patterns were observed on both internal and external surface of device due to repeated use, confirming allegation.However, with information provided, jammed and unable to disassembled condition cannot be confirmed.The wear condition was identified as an end of life indicator; damage consistent with repeated use and servicing over 8 years.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.Since the device was not returned, both dimensional inspection and a functional test cannot be performed.The overall complaint was confirmed as the observed condition of the pin trial shell 58 std profile 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 : 1) quantity manufactured: (b)(4), 2) date of manufacture: 12/8/2016, 3) any anomalies or deviations identified in dhr: n/a, 4) expiry date: n/a, 5) ifu reference: ifu nonsterile inst rev j.

• Brand Name: PIN TRIAL SHELL 58 STD PROFILE
• Type of Device: 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: 18524663
• MDR Text Key: 333004757
• Report Number: 1818910-2024-01086
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295097693
• UDI-Public: 10603295097693
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 221701058
• Device Lot Number: SO2027544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1