MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.133.004
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from australia reports an event as follows: it was reported that during loan kit inspection on january 9, 2024, it was possible to separate the drill and drill guide from each other.There are no surgeon, procedure, or patient details available.This report is for a 2.8mm thrdd guide f/ 3.5mm scr va and lcp.This report is 1 of 1 for (b)(4).
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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a synthes employee.H3, h6: part: 03.133.004.Synthes lot: h889029.Supplier lot: h889029.Release to warehouse date: 19 may 2020.Supplier: (b)(4).No nonconformance reports (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.The product was not returned to depuy synthes, however photos were received for review.The photo investigation did not revealed the reported unable to assemble/disassemble condition for threaded drill guide 2.8 f/screw 3.5 f/v however it shows the signs of usage.Review of provided photo shows the drill and drill guide in contact however without having actual device for evaluation and functional test performed on it, reported allegations cannot be confirmed and cause remains undetermined.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the threaded drill guide 2.8 f/screw 3.5 f/v would not contribute to the complained device issue.Based on the investigation findings, potential cause not established and 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 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 was used for treatment, not diagnosis.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.H3,h4,h6 the device associated with this report was returned to depuy synthes for evaluation.Investigation of the returned device found drill bit ø2.8 qc l135 calibration 45 is stuck inside threaded drill guide 2.8 f/screw 3.5 f/v.Furthermore device shows damaged by usage.A root cause of the observed condition of the devices can not be fully established.Referring to surgical technique se_833017 page 26 notes for a proper usage of the device: the threaded guide can only be threaded at the nominal angle to the plate screw hole for locking and variable locking screw holes.Make a quarter turn counterclockwise to engage the threaded drill guide threads to plate hole threads.A functional test was performed and was able to replicate the reported unable to assemble/disassemble condition due to the devices were unable to disengage.A dimensional inspection was unable to be performed due to the condition of the complaint.The overall complaint was confirmed as the observed condition of the threaded drill guide 2.8 f/screw 3.5 f/v would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The following source controlled drawings reflecting the current and manufactured revisions were reviewed: 03_133_004 rev.B (current) / rev.A (manufactured).Dimensional inspection: n/a.H4,h6 part:03.133.004, synthes lot:h889029, supplier lot:h889029, release to warehouse date: may 19, 2020, supplier: (b)(4).No non conformance reports were generated during production.Device was used for treatment, not diagnosis.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.H10 additional narrative: h3, h6: 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 this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.8MM THRDD GUIDE F/ 3.5MM SCR VA AND LCP
• 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: 18595136
• Report Number: 8030965-2024-01205
• Device Sequence Number: 20878745
• Product Code: FZX
• UDI-Device Identifier: 07612334121981
• UDI-Public: (01)07612334121981
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 03.133.004
• Device Lot Number: H889029
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 02/14/2024; 03/01/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/29/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2020
• 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: UNKNOWN DRILL BITS
• Patient Sex: Unknown