MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PIN TRL LNR +4 10D 560DX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221832156
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there are gouges and cuts on underside of liner.Prone to breakage.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.
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, "gouges and cuts on underside of liner.Prone to breakage." the product was not returned to depuy synthes, however photos were provided for review.See attachment 1000006839.Jpg, 1000006840.Jpg.The photo investigation revealed that pin trl lnr +4 10d 560dx32id had scratches and shows the signs of usage.This type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.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 +4 10d 560dx32id 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 : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code sz0313 provided is not a valid finished goods lot#.
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.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, "gouges and cuts on underside of liner.Prone to breakage." the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that pin trl lnr +4 10d 560dx32id had scratches and shows the signs of usage.This type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.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 +4 10d 560dx32id 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 a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code sz0313 provided is not a valid finished goods lot number.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : gouges and cuts on underside of liner.Prone to breakage.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 product was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that pin trl lnr +4 10d 560dx32id presents several scratches all over the outer surface.Regarding the scratches, this type of damage is consistent with other tools and hard edges coming in contact with the device, properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the pin trl lnr +4 10d 560dx32id 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 : a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code provided is not a finished goods lot number.

• Brand Name: PIN TRL LNR +4 10D 560DX32ID
• 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: 18242150
• Report Number: 1818910-2023-24389
• Device Sequence Number: 6685899
• Product Code: HWT
• UDI-Device Identifier: 10603295100850
• UDI-Public: 10603295100850
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/30/2023

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: 221832156
• Device Lot Number: SZ0313
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 12/05/2023; 05/28/2024; 05/30/2024; 06/04/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/05/2023; 05/31/2024; 05/31/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2013
• 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