MAUDE Adverse Event Report: SYNTHES GMBH NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.120.017
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported multiple devices are no longer functional.These issues did not impact patient outcomes.Below devices were found to be "release mechanism broken" during inspection: 03.043.028 below devices were found to be "stripped threads" during inspection: 03.120.022 312.648 323.029.Below devices were found to be "nut stuck on sleeve" during inspection: 03.037.017 03.037.016 below devices were found to be "handle leaching/spd wil not sterilize" during inspection: 03.100.018 below devices were found to be "broken handle" during inspection: 311.43.Below devices were found to be "stripped drill connection and 2nd is cold welded to a schanz pin" during inspection: 393.103.Below devices were found to be "broken sliding mechanism" during inspection: 319.091.Below devices were found to be "not snapping in" during inspection: 03.120.018 03.120.017.Below devices were found to be "stripped" during inspection: 03.010.151 314.467 03.900.042 03.130.010 314.453 03.010.150 03.010.152.Below devices were found to be "not working properly" during inspection: 329.15.Below devices were found to be "not locking tension between trigger pulls" during inspection: 03.221.015.Below devices were found to be "not aligned" during inspection: 398.65.Below devices were found to be "not locking into aiming arm" during inspection: 03.231.007.Below devices were found to be "bent handle" during inspection: 393.1.Below devices were found to be "trigger detached from handle" during inspection: 03.221.007 below devices were found to be "not sliding properly" during inspection: 319.006 below devices were found to be "shaft pulls out of handle" during inspection: 314.118 below devices were found to be "not locking on" during inspection: 351.16j below devices were found to be "binding on qc attachments" during inspection: 511.773 below devices were found to be "ends not aligning" during inspection: 03.221.011.(b)(4) is the mother complaint.(b)(4) are related to each other and are created to capture additional ips.
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.H11 additional narrative: added: b5 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received: a.Date of event (mm/dd/yyyy): - items identified at various times in preop testing over the last few months.
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, expiration date) d9, h4.Corrected: d4 primary udi number, g1.H3, h6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that neutral drill guide for 4.5 cortex screw exhibited normal signs of use.However, this condition should not affect the functionality of the device.A dimensional inspection for the neutral drill guide for 4.5 cortex screw was not performed as it is not aplicable to reported conditin.A complete functional test was unable to performed as the mating device was not received to assess the interaction, however; the release spring was press and work as expected, no issues were identified.The overall complaint was not confirmed as the observed condition of the neutral drill guide for 4.5 cortex screw would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.There is no indication that a design or manufacturing issue has caused the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part: 03.120.017.Lot: 9446739.Manufacturing site: werk hagendorf.Supplier: na.Release to warehouse date: 11 jun 2015.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.

• Brand Name: NEUTRAL DRILL GUIDE FOR 4.5 CORTEX SCREW
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 24183148
• Report Number: 8030965-2026-00895
• Device Sequence Number: 9578792
• Product Code: FZX
• UDI-Device Identifier: 10886982074157
• UDI-Public: (01)10886982074157(17)411231(10)9446739
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,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: 03.120.017
• Device Lot Number: 9446739
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/17/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/06/2026; 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2015
• 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