MAUDE Adverse Event Report: SYNTHES GMBH 11.0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE; SCREW, FIXATION, BONE

Model Number	04.032.100S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Unspecified Infection (1930); Necrosis (1971); Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from poland reports an event as follows: it was reported that on (b)(6) 2019, a synthes tfn for trochanteric fractures was implanted after a subtrochanteric fracture.On (b)(6) 2019, an x-ray was performed during a followup visit that found suspected damage to the nail.16 days later, the leg with the implant broke for the second time.On (b)(6) 2019 the patient experienced collapse, and on (b)(6) 2019 underwent a procedure to remove the broken tfn nail and to insert a long femoral nail as a replacement.This report is for an 11.0mm ti troch fixation nail screw/100mm ¿ sterile.This is report 1 of 3 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.Event occurred on an unknown date in 2019.Additional procode: hsb.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 04.032.100s, synthes lot # h779735, supplier lot # n/a, release to warehouse date: 26 nov 2018.Manufactured by: synthes monument.No ncrs were generated during production.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.
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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11.0MM TI TROCH FIXATION NAIL SCREW/100MM - STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16689384
• Report Number: 8030965-2023-04240
• Device Sequence Number: 17991350
• Product Code: HWC
• UDI-Device Identifier: 10886982094858
• UDI-Public: (01)10886982094858
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K092646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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,Followup

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.032.100S
• Device Catalogue Number: 04.032.100S
• Device Lot Number: H779735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2018
• 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 - NAILS: TFN; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown