MAUDE Adverse Event Report: SYNTHES GMBH UNK - CABLE/WIRE; CERCLAGE, FIXATION

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that patient had undergone right hip revision due to periprosthetic femur fracture on (b)(6) 2010.Surgeon placed 3 cerclage cables, one distal, one mid section, and one at intertrochanteric line proximally in order to secure fragments into position.During review of imaging on (b)(6) 2018, patient had broken wire in right great trochanteric region, but all the implants around acetabulum remain well-fixed.This report is for an unknown cerclage cable.This is report 1 of 1 for (b)(4).Additional reports are captured under (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.This report is for an unknown cerclage cable/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: bone cement, palacos r (00-112-140-0/6264888), bone screw 6.5x30 m ii acetabular cup self tap (00-66-24-065-30/62654888), bone screw 6.5x40 m ii acetabular cup self tap (00-6624-065-40/62654885), bone screw 6.5x35 m ii acetabular cup self tap (00-6624-065-35/627148148), bone screw 6.5x35 m ii acetabular cup self tap (00-6624-065-35/62714148), bone screw 6.5x40 m ii acetabular cup self tap (00-6624-065-40/62654885), bone screw 6.5x30 m ii acetabular cup self tap (00-6624-065-30/62654888), bone screw 6.5x30 m ii acetabular cup self tap (00-6624-065-30/62654888), bone screw 6.5x30 m ii acetabular cup self tap (00-6624-065-30/62654888), bone screw 6.5x30 m ii acetabular cup self tap (00-6624-065-30/62615477), hip 18mmx305 mm stem wagner (unk part/2683088), liner hip 52iix36 hxpe neutral (00-8751-010-36/62626989), hip 36mm+ 0mm fem head biolox delta option (00-8777-036-02/2747456), cable, grip troch (2232-04-18/6231339), cable, grip troch (2232-04-18/6267379), cable, grip troch (2232-04-18/62591401), cable, grip troch (2232-04-18/62365579), cable, grip troch (2232-04-18/62621142), cable, grip troch (2232-04-18/62285540).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: UNK - CABLE/WIRE
• Type of Device: CERCLAGE, FIXATION
• 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: 15710823
• MDR Text Key: 302941619
• Report Number: 8030965-2022-09192
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,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: 11/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• 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 Sex: Male