MAUDE Adverse Event Report: SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.037.045S

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Unspecified Tissue Injury (4559)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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) 2021, the patient, who was injured on (b)(6) 2021, and treated with external fixation underwent the open reduction internal fixation surgery for trochanteric femur fracture with the tnfa-nail in question.After the surgery, on (b)(6) 2021, the patient underwent the plastic surgical flap operation.The patient was fully weight-bearing on (b)(6) 2021.The patient complained of pain on (b)(6) 2021.The surgeon confirmed broken nail and nonunion on an x-ray on (b)(6) 2021.The patient underwent reoperation, to replace tfna long nails on (b)(6) 2021.The surgeon suggested that the large bone was damage, soft tissue injury, and the delayed weight bearing due to multiple traumas were involved.Procedure was completed successfully without any surgical delay.This report is for one (1) 10mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a device history record (dhr) review was conducted: manufacturing location: monument.Manufacturing date: 15-apr-2020.Expiration date: 01-apr-2030.Part number: 04.037.045s, 10mm/130 deg ti cann tfna 235mm/left ¿ sterile.Lot number: 51p3830 (sterile).Lot quantity: 6.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 41p8486.Lot quantity: 199.One piece was scrapped in cell, ultrasonic clean, as an engineering test sample.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 23p9312.Lot quantity: 1,000.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certificate and certificate of conformance and quality history card were reviewed and determined to be conforming.Part number: 04.037.942.2, lock prong, 130 degree, tfna.Lot number: 29p1353.Lot quantity: 95.Production order traveler met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80.Lot number: 33p1763.Lot quantity: 1,134 lbs.Inspection instruction met all inspection acceptance criteria.Certified test report were reviewed and determined to be conforming.Lot summary report dated 20-dec-2019 met all inspection acceptance criteria.Raw material receiving / putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual, sterility 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.

• Brand Name: 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12370784
• MDR Text Key: 268247740
• Report Number: 8030965-2021-07226
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819649972
• UDI-Public: (01)07611819649972
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.045S
• Device Lot Number: 51P3830
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING; UNK - END CAPS: TFNA; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 66