MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE; NAIL, FIXATION, BONE

Catalog Number	04.043.235S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
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.A1: additional patient identifier: (b)(6).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
It was reported that on (b)(6) 2024, the surgical staff were inserting a tibial nail advanced using the ex suprapatellar sleeves and the ans reaming guide wire.The surgeon started to insert the nail through the metal sleeve and was reminded to remove that first leaving the silicon sleeve only in place.When they pulled the nail out, the peek lining in the distal part of the nail fell out and remained on the guide wire.There was no surgical delay.The procedure was successfully completed.There were no patient consequences/outcome.This report is for one (1) tibial nail-advanced / 10mm 345mm / sterile this is report 1 of 1 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.H3, h4, h6 investigation summary the product was not returned to depuy synthes, however photos were provided for review.Visual inspection of the provided photographic evidence revealed one of the plastic inlays was detached from the tibial nail-advanced / 10 345 / sterile.The rest of the nail was not visible in the provided evidence.The investigation was able to confirmed the reported event.No other problem identified.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 / 10 345 / sterile would contribute to the complained device issue.Based on the investigation findings, the potential cause is attributed to component failure 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 history a manufacturing record evaluation was performed for the finished device product code : 04.043.235s-us lot number# 7271p91 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 05-sep-2023 manufacturing site:jabil bettlach expiry date:31-jul-2033.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.

• Brand Name: TIBIAL NAIL-ADVANCED / 10MM 345MM / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18641539
• Report Number: 8030965-2024-01952
• Device Sequence Number: 20631770
• Product Code: JDS
• UDI-Device Identifier: 10886982297785
• UDI-Public: (01)10886982297785
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: 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: 04.043.235S
• Device Lot Number: 7271P91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: REAM ROD / 3.8 BALL TIP 3.0 / 950 -S; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Patient Age: 70 YR
• Patient Sex: Unknown