MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 3PK RESECTION GDE PIN 3.0X100; FIXATION PIN

Catalog Number	700030100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
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.H11 additional manufacturer narrative: d4: udi: as the catalog/model number was not provided, the (01)gtin is not available.
Event or Problem Description
It was reported that the pin stuck in resection guide.Another was available and the case proceeded as planned.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according for information received, it was reported that the pin stuck in resection guide.Another was available and the case proceeded as planned.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection revealed the 3pk resection gde pin 3.0x100 stuck though one of the divergent pin holed of silhouette resection guide.Additionally, the body of the pin was found delaminated.Potential cause can be attributed to unintended use error, as this type of damage is consistent with the pin being drilled in a misaligned position.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was performed and was able to replicate the reported jammed condition due to the devices were not able to disengage after multiple attempts with excessive forces applied.The overall complaint was confirmed as the observed condition of the 3pk resection gde pin 3.0x100 would have contributed 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: 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.Added: d4 (lot, expiration date, primary udi number), g4 (pma/ 510(k)), h4.Corrected: d1, d2a, d3, d4 (catalog), h3, h5.
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 recon described in this report.H11 additional narrative: added: d9 if information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.

• Brand Name: 3PK RESECTION GDE PIN 3.0X100
• Common Device Name: FIXATION PIN
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24123540
• Report Number: 1818910-2026-01190
• Device Sequence Number: 20346301
• Product Code: LXH
• UDI-Device Identifier: 10603295538530
• UDI-Public: (01)10603295538530(17)300630(10)233606
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 700030100
• Device Lot Number: 233606
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 02/27/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/09/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female