MAUDE Adverse Event Report: DEPUY SPINE INC PRIME FEN ALIGNMENT DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286750150
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was a posterior spinal fusion(l4/5) procedure for sacral fracture.During the surgery, after placing the alignment device on the screw, the surgeon checked to see if the open cannula could pass through, but the open cannula would not go through.The sales rep checked the orientation of the alignment device several times and reattached it, but it still would not go through.There was no problem with the orientation of the screw, and of course the open cannula was not bent.Therefore, the surgeon tried cleaning the alignment device with a guide wire outside the operating field, and although the guide wire went through normally, the open cannula still would not go through.It seemed that the thicker part of the open cannula was getting caught somewhere in the alignment device, so the surgeon removed and reinserted the guide wire to clean it again, and white and black debris, some foreign matter came out.It's possible that cement or blood from the previous or earlier operation had hardened and stuck to the inside of the alignment device.The surgery was completed successfully within 30 mins of delay.Patient outcome is reported as stable.No further information is available.
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 medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d4 (lot), d9, d10.Corrected: d4 (primary udi #).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.D4: udi: as the lot number for the device involved in the event was for dhr review, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: corrected: h4.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the interior of the device was observed with a foreign unknown matter.A complete functional test can not be performed with out mating device, however due to the observed condition, an issue with correct assembly can be confirmed.Potential cause can be traced to maintenance, refer to the device/country specific ifu for information related to cleaning, sterilization, reprocessing instructions, and inspection procedures.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 prime fen alignment device 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.A review of the receiving inspection (ri) for prime fen alignment device conducted identifying that lot number gm6280309 released in one batch.Batch1: lot qty of (b)(4) units were released on apr 4, 2024 with no discrepancies.Supplier: (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PRIME FEN ALIGNMENT DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23843643
• Report Number: 1526439-2025-01775
• Device Sequence Number: 9958051
• Product Code: LXH
• UDI-Device Identifier: 10705034529776
• UDI-Public: (01)10705034529776(10)GM6280309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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

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: 286750150
• Device Lot Number: GM6280309
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 01/14/2026; 01/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/16/2026; 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRIME FEN ALIGNMENT DEVICE; UNKNOWN SCREWS
• Patient Sex: Unknown