MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 390MM / STERILE; NAIL, FIXATION, BONE

Catalog Number	04.043.350S
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
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.D2: additional procode: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: 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 the united kingdom reports an event as follows: it was reported that on (b)(6) 2024, intermedullary fixation with the tna nail was performed for a midshaft fracture to the right tibia.During the procedure, the surgeon had difficulty implanting the 11mm tna.It was identified that the nail was too large and so it was removed to be exchanged with one of a smaller diameter.The nail along with the reaming rod that was stuck inside of the nail were removed.After removal it was noticed that the distal poly inlay of the nail had been pushed and twisted.A 10mm tna was implanted successfully.There was no reported adverse patient impact.No further information is available.This report is for a tibial nail-advanced / 11mm 390mm / sterile.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: photo investigation: the product was not returned to depuy synthes, however a photo was provided for review.The photo investigation revealed that distal end of the implant is observed and that one of the distal inlay appears to be deformed.Even though, it is not possible to perform a functional test through photo evidence it is possible based on available information and photo evidence to confirm an assembling issue.Furthermore, there is no evidence provided to confirm fell apart condition.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the tibial nail advanced ø11 l390 would contribute to the complained device issue.Based on the investigation findings, potential cause is traced to user, 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.H6: a manufacturing record evaluation was performed for the finished device product code # 04.043.350s.Lot # 89p3445.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 04-may-2021.Manufacturing site:jabil bettlach.Expiry date:01-apr-2031.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
It was reported that there was no surgical delay.The tibial nail advanced with the poly inlay became loose.

• Brand Name: TIBIAL NAIL-ADVANCED / 11MM 390MM / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18979286
• Report Number: 8030965-2024-04097
• Device Sequence Number: 6693798
• Product Code: JDS
• UDI-Device Identifier: 10886982298263
• UDI-Public: (01)10886982298263
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K201336
• 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: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.043.350S
• Device Lot Number: 89P3445
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - REAMING RODS
• Patient Sex: Unknown