MAUDE Adverse Event Report: SYNTHES GMBH 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.114.001
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that patient underwent open reduction and fixation of a phalanx in a hand fracture on (b)(6) 2025.The guide did not thread easily into the blocked holes.It had been decided to use a 1.5 plate.The doctor was informed in advance that the lcp equipment had been sent to him.The plate was trimmed and implanted.The locking guide did not thread into the head holes, so the doctor decided to drill freehand.The screws did not lock, causing instability of the fracture.The doctor decided to remove the hardware and leave pins from the institution.The specialist preferably required hand-held equipment.
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: h3, h6: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photo investigation revealed that the threaded tip of the 1.1 lcp thrd drill guide for 1.5 lcp pls showed no cosmetic defects.However, functionality of the device cannot be assessed through photo evidence provided.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 not confirmed as the observed condition of the 1.1 lcp thrd drill guide for 1.5 lcp pls would have not 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 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 review: part # 03.114.001, synthes lot # h363238, supplier lot # h363238, release to warehouse date: 14 nov 2017, supplier : (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: d9, d10.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 that the 1.1 lcp thrd drill guide for 1.5 lcp pls tip is cross threaded, no other issue was observed.The observed condition is consistent with a component failure that may have been caused by unintended forces, with the damage likely resulting from off-axis assembly, prying motion while assembling.A functional test was performed and revealed that the drill guide was unable to fully assemble on the plate, due to the observed damage on the tip, the reported allegation was able to be confirmed.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 1.1 lcp thrd drill guide for 1.5 lcp pls would have 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: part # 03.114.001.Synthes lot # h363238.Supplier lot # h363238.Release to warehouse date: 14 nov 2017.Supplier : (b)(4).No ncrs were generated during production.Device history batch: null.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 21587513
• Report Number: 8030965-2025-02393
• Device Sequence Number: 8895948
• Product Code: FZX
• UDI-Device Identifier: 10886982072986
• UDI-Public: (01)10886982072986(10)H363238
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• 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: 03.114.001
• Device Lot Number: H363238
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 03/14/2025; 03/10/2026; 03/24/2026
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 03/18/2025; 03/17/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2017
• 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: 1.5MM LCP T-PLATE/4H HEAD 8 HOLE SHAFT.; CORTSCR Ø1.5 SELF-TAP L7 SST.; LOCKSCR Ø1.5 SELF-TAP L10 SST.; LOCKSCR Ø1.5 SELF-TAP L10 SST.; LOCKSCR Ø1.5 SELF-TAP L6 SST.
• Patient Age: 50 YR
• Patient Sex: Unknown