MAUDE Adverse Event Report: SYNTHES GMBH BOLT Ø4.9 SELF-TAP L34 TAV GREEN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 459.340VS

Device Problem Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

Date of event: event is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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: it was reported that on (b)(6) 2018, the patient underwent an unknown surgery for proximal femoral nail antirotation (pfna).The surgery was completed successfully without any surgical delay.On (b)(6) 2022, it was confirmed that cut-out occurred.The revision surgery was done on (b)(6) 2022.The pfna was removed and replaced with an artificial head.The surgeon commented that femoral neck fracture was the cause of the cut-out.It is unknown when the femoral neck fracture occurred.This is report 4 of 4 for complaint (b)(4).This report is for pfna bolt.

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.H10 additional narrative: h3, h6: part # 459.340vs.Lot # 5943787.Manufacturing site: werk selzach.Release to warehouse date: 05 sep2017.Expiration date: 01 sep2027.Supplier: synthes österreich gmbh.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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: BOLT Ø4.9 SELF-TAP L34 TAV GREEN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14356806
• MDR Text Key: 291385939
• Report Number: 8030965-2022-03127
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819702523
• UDI-Public: (01)07611819702523
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.340VS
• Device Lot Number: 5943787
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: PFNA BLADE; UNK - NAILS: PFNA
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female