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

Model Number	04.043.335S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Joint Contracture (4528)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem 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).
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.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
• 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 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16574090
• Report Number: 8030965-2023-03395
• Device Sequence Number: 17637348
• Product Code: JDS
• UDI-Device Identifier: 10886982298232
• UDI-Public: (01)10886982298232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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

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