MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC TFNA SCREW 110MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.038.110S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(6).Date of postoperative tfna screw back out is unknown.Not explanted.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient experienced ski accident and presented with a right femur fracture on an unknown date.It was also reported that the patient was under the influence of alcohol at the time of the event.On (b)(6) 2018, an original surgery to treat to femur fracture using trochanteric nail fixation advanced system (tfn-a) was performed.Patient was implanted with one(1) tfn-a nail, (1) lag screw, two (2) locking screws.The initial procedure was completed successfully without any delay.All the devices were successfully implanted and this was confirmed by intra-operative x-rays.During a follow up visit on an unknown date, post-operative x-rays revealed that the lag screw was progressing/backing out from the nail laterally.Patient did not experience pain nor have any other adverse event.It has not been decided yet if the patient will undergo revision surgery.Concomitant devices reported: 10 mm/130 deg titanium cannulated tfna 380 mm/right (part number 04.037.058s, lot number h190868, quantity 1).This report is for one (1) tfna screw 110mm - sterile.(b)(4).

Manufacturer Narrative

Dhr review was completed.Part number: 04.038.110s lot number: 7920234 date of manufacture: 19 march 2015 place of manufacture: (b)(4) part expiration date: 28 february 2025 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 110mm sterile product was processed through the normal manufacturing and inspection operations with no 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.H3, h6: customer quality conducted a review of the provided x-rays.One tfna helical blade (part 04.038.110s | lot 7920234) was reported with the complaint category of ¿functional: migration/backout/pull-out : rm.¿ a visual inspection via the provided x-rays and pictures, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The complaint condition could not be confirmed.No new malfunctions were observed during the course of this investigation.The reported device was not received for investigation.The investigation is based on the reported information and provided x-rays.Device condition: the provide picture shows the proximal end of a tfna head element.Due to the resolution, minimal detail can be gathered, however, no product issues were observed in the image.The provided x-rays do not show the distal tip of the tfna helical blade which was reported to have cut out or the nail/blade junction.Thus, the complaint condition could not be confirmed.Replication of the condition is not applicable for this complaint condition.Lot number review: date of manufacture: 19march2015 a review of the device history record and the raw material device history record revealed this lot met all specifications and the lot went through the required steps during the inspection at the time of manufacturing and the dhr records showed no issues concerning the material or material conditioning.Drawing review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.Ti tfna helical blade: during the investigation no product design issues were observed that may have contributed to the complaint condition.As the physical device was not received no further dimensional or material testing could be completed.Risk assessment review: the trochanteric fixation nail - advanced (tfna) design and clinical risk management (dcrm) document, was reviewed and found to adequately address the complaint condition.Root cause: no definitive root cause was able to be determined as circumstances surrounding the event are unknown.It was reported that the user suspected they forgot to engage the locking mechanism during the initial surgery which would impact the complaint condition of migration.However, as the device was not returned a root cause could not be determined.No design of manufacturing issue was identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: TFNA SCREW 110MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7230444
• MDR Text Key: 98670917
• Report Number: 2939274-2018-50440
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098559
• UDI-Public: (01)10886982098559(17)EXPIRATIONDATEUNKNOWN(10)7920234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.110S
• Device Catalogue Number: 04.038.110S
• Device Lot Number: 7920234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 03/26/2018
• Date Device Manufactured: 03/19/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 91