MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L80 TAN; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.380S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Malunion of Bone (4529)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, the patient underwent the open reduction internal fixation with the tfna for the fracture of the trochanteric femur.The surgery was completed successfully without any surgical delay.However, the pseudarthrosis has occurred, and there was a possibility that the implant will break, or cut-out will occur, so that the surgeon will remove the tfna and perform the bipolar hip arthroplasty on (b)(6) 2022.According to the surgeon, the pseudarthrosis occurred because the femoral bone head was fixed with an outward bow and a gap in the calcar part.The surgeon had a poor impression with synthes product since the case of malfunctions continue.No further information is available.This complaint involves only four(4) devices.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary: 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 history lot: product code #: (b)(4).Synthes lot #: 83p2706.Manufacturing site: (b)(4).Release to warehouse date: 06jan2021.Expiration date: 01jan2031.Supplier: synthes usa hq, inc.A manufacturing record evaluation was performed for the non-sterile article lot and no non-conformances were identified.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: TFNA HELICAL BLADE PERF L80 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13830442
• MDR Text Key: 287556791
• Report Number: 8030965-2022-01757
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652552
• UDI-Public: (01)07611819652552
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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: 03/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.380S
• Device Lot Number: 83P2706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L34 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL 12 125 L200 T; TFNA HELICAL BLADE PERF L80 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 50 KG