MAUDE Adverse Event Report: SYNTHES GMBH TFNA SCR PERF L80 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.180S

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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 history lot: part number: 04.038.180s, lot number: 475p651, part manufacture date: 24-mar-2020, manufacturing location: (b)(4), part expiration date: 01-mar-2030, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated screw 80mm - sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot was shipped from elmira to monument as part number 04.038m180sp, lot number 45p6391, and assigned as part number 04.038.180s for final packaging.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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) 2021, the patient underwent the open reduction internal fixation surgery for sub-trochanteric fracture of femur with the nail, the end cap, the locking screw and the screw in question.The surgery was completed successfully without any surgical delay.After the surgery, the patient had been able to walk with a cane with immediate full weight bearing.The patient was followed up on a monthly basis after discharge, and although bone contact was confirmed, callus bridging was not confirmed.On (b)(6) 2021, the patient visited the hospital complaining of pain while walking, and it was found that the nail opening was broken.On (b)(6) 2021, the patient underwent the revision surgery and the fractured nail was removed.The patient was revised with two rag fixes inserted into the bone head and the affected area was fixed again with a gamma 3 -120 °f12-170 mm and u lug screw 80 mm.The revision surgery was completed successfully without any surgical delay.The surgeon commented that stress concentration and accumulation of metal fatigue due to delayed bone union were thought to have led to implant fracture, and that patient-derived delayed bone union was the main cause of nail fracture since the patient had atypical fracture and 10 years of treatment for osteoporosis.No further information is available.This report is for one (1) tfna scr perf l80 tan.This is report 4 of 4 for (b)(4).

• Brand Name: TFNA SCR PERF L80 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12632787
• MDR Text Key: 276404362
• Report Number: 8030965-2021-08685
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652293
• UDI-Public: (01)07611819652293
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.180S
• Device Lot Number: 47P5651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; TFNA END CAP EXTENS. 0 TAN; TFNA FEM NAIL Ø10 R 125° L280 TIMO15
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR