MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SOLO PINNING SYSTEM; FIXATION PINS

Catalog Number	254400111
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent knee surgery on (b)(6) 2025.Intraoperatively, a pin from the attune pinning system repeatedly got stuck in the cutting blocks (bent, metal nose, or both).Other pins have been used on the blocks and worked perfectly well.This complicated the surgery but had no impact on the outcome.
Additional Manufacturer Narrative
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 narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
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.H11 additional narrative: added: d4 (expiry date), d9, h4.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: intraoperatively a pin from the attune pinning system repeatedly got stuck in the cutting blocks (bent, metal nose, or both).This complicated the surgery but had no impact on the outcome.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachments "(b)(4) source doc - not to be translated and (b)(4) photos".The device associated with this report was not returned to j&j medtech orthopedics for evaluation.The photographs attached were reviewed, however the image quality is poor and no observations pertaining to the nature of the reported event could be identified.Additionally, the device was observed to be disassembled.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs attached are insufficient to draw a conclusion about the reported event.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 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: (b)(4).2) date of manufacture: 12/31/2024.3) any anomalies or deviations identified in dhr: none.4) expiry date: 11/30/2026.5) ifu reference: ifu-78410359.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: intraoperatively a pin from the attune pinning system repeatedly got stuck in the cutting blocks (bent, metal nose, or both).The product was returned to depuy synthes for evaluation.Visual inspection reveled that the attune solo pinning system was returned disassembled.Additionally, it is bent at its proximal part.No other anomalies were noted.The observed condition of the device was consistent with off axis insertion and an exposure to unintended forces, like usage of excessive force in a prying motion during the assembling process.A functional test was unable to be performed since the mating device was not returned and although the observed bent condition of the attune solo pinning system proximal part can lead to the "repeatedly got stuck" issues as reported, as the device was returned disassembled and without a proper functional test, this allegation cannot be confirmed a dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was not confirmed as the observed condition of the attune solo pinning system would have not contributed to the complained issue.Based on the investigation findings, 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 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: 12/31/2024 3) any anomalies or deviations identified in dhr: none 4) expiry date: 11/30/2026 5) ifu reference: (b)(4).Device history review: a manufacturing record evaluation was performed for the finished device m8219x number, and no non-conformances / manufacturing irregularities were identified during manufacturing.H11 additional narrative: corrected: d4 (primary udi number), g4 [pma/ 510(k)], h3.The expiration date (11/30/2026) in the previous medwatch was reported in error.The device involved was an instrument and does not have an expiration date.

• Brand Name: ATTUNE SOLO PINNING SYSTEM
• Common Device Name: FIXATION PINS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23109643
• Report Number: 1818910-2025-16223
• Device Sequence Number: 15910886
• Product Code: LXH
• UDI-Device Identifier: 10603295129943
• UDI-Public: (01)10603295129943(10)M8219X
• 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

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: 254400111
• Device Lot Number: M8219X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 11/11/2025; 11/21/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/12/2025; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown