MAUDE Adverse Event Report: SYNTHES GMBH TI END CAP FOR TFNA 0MM EXTN - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.000S

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a synthes employee.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) 2017, the patient underwent the open reduction internal fixation surgery for the right femoral shaft fracture with the tfna implants and 3 nesplon cables.The surgery was completed successfully without any surgical delay.Since 2019, the patient's right femur felt strange.On (b)(6) 2020, the patient could not walk due to pain.On (b)(6) 2020 the surgeon confirmed that the nail had broken at the non-union part.The patient will undergo the revision surgery on (b)(6) 2021.In the revision, the broken nail will be removed, and new implants will be set.The patient has rheumatoid arthritis, diabetes, osteoporosis and chest spinal canal stenosis.The patient also has an allergy to the metal.Concomitant devices reported: 10mm/125 deg ti cann tfna 300mm/right - sterile (part number 04.037.020s, lot h036461, quantity 1), tfna helical blade 80mm sterile (part number 04.038.280s, lot h201009, quantity 1), lockscr 5 l32 f/nails tan light green (part number 04.005.522s, lot l047405, quantity 1), lockscr 5 l32 f/nails tan light green (part number 04.005.522s, lot l100374, quantity 1).This report involves one (1) ti end cap for tfna 0mm extn - sterile.This is report 2 of 5 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: g1: physical manufacturer.H3, h4, h6: part 04.038.000s, lot l318262: manufacturing location: bettlach.Manufacturing date: march 16, 2017.Expiration date: march 01, 2027.A manufacturing record evaluation was performed for the finished device lot number, 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.H11: corrected data: h4.

• Brand Name: TI END CAP FOR TFNA 0MM EXTN - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11202396
• MDR Text Key: 227798425
• Report Number: 8030965-2021-00439
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819648708
• UDI-Public: (01)07611819648708
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 04.038.000S
• Device Lot Number: L318262
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2021
• Patient Sequence Number: 1
• Treatment: LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø10 R 125° L300 TIMO15; TFNA HELICAL BLADE L80 TAN; LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; LOCKSCR 5 L32 F/NAILS TAN LIGHT GREEN; TFNA FEM NAIL Ø10 R 125° L300 TIMO15; TFNA HELICAL BLADE L80 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 40