MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 105MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.038.105S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 5 feet 7 inches.Patient id/initials are unknown.Unknown date in 2018.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 the patient underwent a revision procedure on may 15, 2018 due to a fall and trochanteric fixation nail advanced (tfna) lag screw cut-out of the femoral head.The nail was removed and the patient was revised to a dynamic hip and condylar screw system (dcs).Surgical delay and patient outcome are unknown.The patient was initially implanted with the hardware on (b)(6) 2018.After the initial surgery, the patient fell on an unknown date causing the lag screw cut-out.Concomitant devices reported: 9mm/125 degree titanium cannulated tfna 235mm/left - sterile (part 04.037.915s, lot h484110, quantity 1), screw (part unknown, lot unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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

Further it was reported that the nail and screw were removed easily.No surgical delay was reported and the procedure was completed successfully.Concomitant medical products: 9mm/125 degree titanium cannulated tfna 235mm/left - sterile (part # 04.037.915s, lot # h484110, quantity # 1), 5.0mm titanium locking screw w/t25 stardrive 46mm for intramedullary nails (part # 04.005.536, lot # unknown, quantity # 1).

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.Patient ethnicity is unknown.Part: 04.038.105s; lot: h395899; date of manufacture: august 10, 2017; place of manufacture: elmira; part expiration date: july 31, 2027; nonconformance noted: n/a description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna screw 105mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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 non-conformance 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.The following investigation flow was performed: device interaction/functional.Visual inspection performed at customer quality (cq) of the returned device showed wear consistent with implantation and explantation.However, no damage that would contribute to the reported complaint condition was observed.No x-rays/radiographs showing the reported cut-out condition were provided, therefore this complaint was not able to be confirmed.A relevant functional test to replicate the reported complaint condition was not able to be performed at cq because this was a post-operative event.The returned device was manufactured in august 2017.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna screw 105mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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 non-conformance 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.Tabulated product drawing for the family of titanium trochanteric fixation nail advanced (tfna) screws was reviewed during this investigation.No product design issues or discrepancies were observed.The distal major thread diameter for the returned device measured ø10.24mm at cq (ca592) which is within specification of ø10.3mm +0/-0.1mm per tabulated product drawing.It was determined that no other features are relevant to this complaint condition.The complaint histories for the tfna helical blade and screw families (04.038.070-425) was reviewed from 1/2014 (system launch) through 7/2018.Implant sales (289,754 sold) were utilized to calculate an occurrence rate of 0.0580%.The risk assessment for tfna addresses the hazard ¿head element cut out in the femoral head superiorly, collapse of femoral head, or varus deformity may occur post-surgery which may lead to patient harm;¿ the highest severity of harm of major (4) and an unlikely likelihood of harm (2) which has a probability of occurrence of >0.01% and

• Brand Name: TFNA SCREW 105MM - 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: 7570232
• MDR Text Key: 110109273
• Report Number: 2939274-2018-52411
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098535
• UDI-Public: (01)10886982098535
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.038.105S
• Device Catalogue Number: 04.038.105S
• Device Lot Number: H395899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 70