MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 11MM 345MM / STERILE; NAIL, FIXATION, BONE

Model Number 04.043.335S

Device Problem Use of Device Problem (1670)

Patient Problem Joint Contracture (4528)

Event Date 02/28/2023

Event Type  Injury  

Event Description

Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the 34-year-old male patient underwent the unknown surgery for tibia with tna.This is a report of a nail top protrusion that resulted in the removal surgery to replace it.Although there was some hesitation in nail sizing due to the deep distal nature of the case, the nail in question was fixed with the nail top protruding approximately 5 mm.The nail was inserted just to the distal tibial articular surface, and the surgeon determined that further insertion would be difficult, so the wound was closed in anticipation of early removal.The nail replacement was scheduled to be performed on (b)(6) 2023.According to the surgeon, the decision to replace the nail was based on concerns about knee contracture.This report is for a tibial nail-advanced / 11mm 345mm / sterile.This is report 1 of 1 for (b)(4).

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.Additional procode: hwc.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.The initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: TIBIAL NAIL-ADVANCED / 11MM 345MM / STERILE
• Type of Device: 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 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16574090
• MDR Text Key: 311659443
• Report Number: 8030965-2023-03395
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982298232
• UDI-Public: (01)10886982298232
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.043.335S
• Device Catalogue Number: 04.043.335S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male