MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE TIB PREP & IMPACT; ATTUNE INSTRUMENTS : INSTRUMENT CASES

Catalog Number	254501702
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by central sterile services department (cssd) that the plastic coating is delaminating from metal tray.
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.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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - according to the information received that "cssd is complaining the instrument tray as the plastic coating is delaminating from metal tray." this complaint involves one (1) device.The product was not returned to medtech orthopedics; however, photos were provided for review.See attachment "(b)(4) photos".The photo investigation revealed that ¿254501702, attune tib prep & impact¿ has peeling coating.The observed condition was identified as an end-of-life indicator, damage consistent with repeated use and servicing.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.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune tib prep & impact would contribute to the complained device issue.Based on the investigation findings, attune tib prep & impact was peeling coating because of end of life, 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 medtech orthopedics 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 device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be reassessed.
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 that "cssd is complaining the instrument tray as the plastic coating is delaminating from metal tray." this complaint involves one (1) device.The product was not returned to medtech orthopedics; however, photos were provided for review.The photo investigation revealed that ¿254501702, attune tib prep & impact¿ has peeling coating.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune tib prep & impact would contribute to the complained device issue.Based on the investigation findings, attune tib prep & impact was peeling coating because of end of life, 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 medtech orthopedics 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 device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be reassessed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : cssd is complaining the instrument tray as the plastic coating is delaminating from metal tray.See photos.The product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the plastic coating covering the brackets, was peeling off.Additionally, the graphics on the inside and outside of the tray were pealing.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.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.A functional test was not performed since it was not applicable to the complaint condition.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 attune tib prep & impact would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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 : 1) quantity manufactured:120.2) date of manufacture: 11/20/2013.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu reference: ifu-0902-60-001.Device history review : 1) quantity manufactured:120.2) date of manufacture: 11/20/2013.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a.5) ifu reference: ifu-0902-60-001.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE TIB PREP & IMPACT
• Common Device Name: ATTUNE INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21518937
• Report Number: 1818910-2025-03423
• Device Sequence Number: 21260841
• Product Code: FSM
• UDI-Device Identifier: 10603295423522
• UDI-Public: (01)10603295423522(10)PV0054574
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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

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: 254501702
• Device Lot Number: PV0054574
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/20/2025; 06/12/2025; 06/27/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/21/2025; 06/13/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2013
• 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