MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS; EXTRACTOR

Catalog Number 357.133

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Concomitant medical products: concomitant device therapy date reported as approximately 3 years prior to removal, exact date is not known.Initial reporter is synthes sales consultant.Without a lot number the device history records review could not be completed.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: patient was implanted with an unknown tibia nail on unknown date approximately three (3) years prior to removal.On unknown date, patient suffered a fall that resulted in a fractured tibia and a broken tibia nail.Patient was returned to surgery on (b)(6) 2018 for removal of the broken device.During the removal process, surgeon was unable to thread the extraction screw for femoral and tibial nails onto the broken tibia nail.The threads appeared to be frayed and crossed, preventing the device from holding onto the nail and causing it to slide off.Surgeon was able to hit the nail from below and used a competitor¿s extractor to remove the nail.Surgery was completed with a delay of approximately 10 minutes.No patient consequence was reported.The revision surgery is addressed in (b)(4).This report addresses the intraoperative issue with the extraction screw.Concomitant device reported: tibial nail (part number unknown, lot number unknown, quantity 1).This report is for one (1) extraction screw for femoral and tibial nails.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.Additional narrative: patient ethnicity is unknown.Lot number is now known.Device evaluated by mfr: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device manufacture date: date of manufacture is now known.Corrected data: concomitant medical products.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.

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.A device history record (dhr) review was conducted for part: 357.133, lot: 3231866: manufacturing site: synthes werk bio oberdorf (ch), release to warehouse date: 17.Aug.2009: the device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of damaged threads, which agrees with the reported complaint condition.The distal threadform that mates with nails shows post manufacturing deformation.There are several areas which have rolled thread edges and deformed threads.The entire device shows superficial surface wear.The damaged threadform is suggestive of previously cross threading the device with a mating nail.Functional test: a functional test in effort to replicate the reported complaint condition of difficulty assembling with a nail could not be performed at cq because the nail involved in the event was not returned.However, the noted thread damage would contribute to reported complaint condition.Therefore, the received condition of the device agrees with the reported condition of the device and the complaint condition is confirmed.Document/specification review: the returned device was manufactured in august 2009.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Extraction screw design drawings were reviewed during this investigation.The extraction screw for ti femoral and tibial nails (part# 357.133) is a reusable trauma instrument, noted in approximately eleven (11) nail system technique guides including: titanium cannulated tibial nails system, adolescent lateral entry femoral nail system and titanium retrograde/antegrade femoral nail system.In each instance the extraction screw is available if implant removal is desired.The extraction screw is threaded into the implanted nail and a hammer guide is attached to the extraction screw allowing for implant removal with light hammer blows.No product design issues or discrepancies were observed.Dimensional inspection: a dimensional inspection was not able to be performed at customer quality (cq) because of the post manufacturing damage.Conclusion: a definitive root cause for the returned 6+ year old extraction screw becoming damaged could not be determined based on the provided information.The failure mode is typically associated with attempted off-axis insertion leading to thread deformation.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7570851
• MDR Text Key: 110175733
• Report Number: 2939274-2018-52414
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: 3231866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 07/03/2018; 08/02/2018
• Supplement Dates FDA Received: 07/23/2018; 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1