MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH TIB-NAIL Ø10 L345; NAIL, FIXATION, BONE

Catalog Number 04.043.235S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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 Description

Device report from synthes reports an event in (b)(6) as follows: this (b)(4) is related to (b)(4) which reports about the difficulty inserting nail which occurred in the first surgery.This pc reports about the secondary fracture which occurred after the surgery.It was reported that on (b)(6) 2022, the patient underwent the surgery for the tibial shaft fracture with the nail in question.The surgery was completed successfully without any surgical delay.After the surgery, it was confirmed that there was a crack near the entry point of the proximal tibia.This crack did not cause fixed anxiety or clinical problems.No further information is available.Concomitant device: unknown screws (part# unknown, lot# unknown, quantity unknown) this complaint involves one (1) device tib-nail ø10 l345.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TIB-NAIL Ø10 L345
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14493560
• MDR Text Key: 292570844
• Report Number: 9612488-2022-00014
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07612334171528
• UDI-Public: (01)07612334171528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.043.235S
• Device Lot Number: 125P224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Sex: Male