MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.042S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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

It was reported that on (b)(6) 2020, during an unknown procedure the trochanteric fixation nail advanced (tfna) short nail was broke at the junction of the blade.On (b)(6) 2019, patient received a short trochanteric fixation nail advanced (tfna) for an unstable intertrochanteric fracture.On (b)(6) 2020 patient underwent surgery for removal of broken hardware and received a total hip replacement.A second surgery due to hw failure.Fragments generated from broken device and was difficult and required additional intervention to remove as expected by the surgeon.There was no surgical delay.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: fenestrated helical blade 90mm (part#: 04.038.390, lot#: h835094, quantity: 1).This complaint involves one (1) device.This report is for (1) 10mm/130 deg ti cann tfna 170mm - sterile.This is report 1 of 1 for (b)(4).

Event Description

Updated event description: it was reported that on an unknown date, the trochanteric fixation nail advanced (tfna) short nail broke at the junction of the blade.On (b)(6) 2019, the patient received a short trochanteric fixation nail advanced (tfna) for an unstable intertrochanteric fracture.On (b)(6) 2020 patient underwent surgery for removal of broken hardware and received a total hip replacement.Had a second surgery due to hw failure.There were fragments generated from the broken device and were removed as expected by the surgeon.Procedure was successfully completed.Patient status is unknown.Concomitant device reported: fenestrated helical blade 90mm ((part#: 04.038.390, lot#: h835094, quantity: 1(b)(4)), unknown screws: locking: trauma ((part#: unknown, lot#: unknown, quantity: (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.B5: updated event description and concomitant devices h3, h6: a product investigation was conducted.Visual inspection: the 10mm/130 deg ti cann tfna 170mm - sterile (p/n 04.037.042s lot h850290) was received at uscq.Upon visual inspection it was noticed that the device was broken through the walls of the helical blade opening of the nail.No drill marks or any other visual issues were identified on the device.The device failure/defect of broken was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: drawing: 10mm ti cannulated trochanteric femoral nail-advanced, feature: outer diameter result: conforming document/specification review: the relevant drawings, reflecting the manufactured and current revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the 10mm/130 deg ti cann tfna 170mm - sterile (p/n 04.037.042s lot h850290) as the implant was received broken into two pieces.While no definitive root cause could be determined, it is possible that condition was due to early excessive strain by patient and/or unintended forces.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H4, h6: a device history record (dhr) review was conducted: manufacturing location: monument, manufacturing date: 19-mar-2019, expiration date: 28-feb-2029, part number: 04.037.042s, 10mm/130 deg ti cann tfna 170mm ¿ sterile, lot number: h850290 (sterile) , lot quantity: (b)(4).Work order traveler 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.Component part(s) reviewed: part number: 04.037.942.2, lock prong, 130 degree, tfna bp55, lot number: 3l32080, lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Part number: 04.037.912.4, wave spring, shim ended bp55, lot number: h761716, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Material certification and certificate of conformance and quality history card were reviewed and determined to be conforming.Part number: 04.037.912.3, tfna lock drive bp58, lot number: h825388, lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Part number: 21127, timoagri16.00 bp80, lot number: h823170, lot quantity: (b)(4).Certificate of analysis was reviewed and determined to be conforming.Lot summary report dated 23-jan-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 170MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10634650
• MDR Text Key: 209979529
• Report Number: 2939274-2020-04503
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982095985
• UDI-Public: (01)10886982095985
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.042S
• Device Catalogue Number: 04.037.042S
• Device Lot Number: H850290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Date Manufacturer Received: 10/07/2020
• Patient Sequence Number: 1
• Treatment: TFNA FENESTRATED HELICAL BLADE 90MM; TFNA FENESTRATED HELICAL BLADE 90MM; UNK - SCREWS: LOCKING; TFNA FENESTRATED HELICAL BLADE 90MM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 77