MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number	352.040
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
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 j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
Device report from depuy synthes reports an event in canada as follows: it was reported that on (b)(6) 2023, during a trochanteric fixation nail - advanced (tfna) procedure, along with the synream medullar shaft had broken inside the patient's femur during the reaming stage.The surgeon proceeded to cut the current guide wire in the shaft at the site of the fracture, removing it, then using a new ball tip guide wire to remove the metal fragments through a created open incision.The surgeon was able to remove the fragments with this strategy approximately 45 minutes after observing the broken reamer, but was quite upset with the device malfunction.Once removing 3/4 fragments using x-rays, leaving a small fragment in the femur, the surgeon continued with the tfna procedure according to the plan and successfully closed within the next hour with an 11/360mm nail and an 85mm blade.Procedure was completed successfully with 45 minutes of surgical delay.This report is for one (1) 5.0mm flexible shaft.This is report 1 of 2 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: the product was not returned to depuy synthes, however photos were provided for review.The device associated with this report was not returned to depuy synthes for evaluation.The photo investigation found that the 5.0mm flexible shaft was broken, associated to the current complaint, confirming the report allegation.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 confirmed as the observed condition of the 5.0mm flexible shaft 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SALZBURG; vorgartenstrasse 206b; salzburg 1020 WIEN; AU 1020 WIEN
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17379137
• Report Number: 8030965-2023-09191
• Device Sequence Number: 12361965
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 352.040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.5MM MEDULLARY REAMER HEAD; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - NAILS: TFNA; UNK - REAMERS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown