MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/85MM; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Model Number 02.231.285

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product codes hrs, hwc.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.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

It was reported that the patient underwent a revision surgery on (b)(6) 2018, due to a loss of distal fixation.The patient initially had an open reduction internal fixation left femur surgery on (b)(6) 2018.A variable angle locking compression plate (lcp) condylar plate was implanted with four (4) locking screws distally and four (4) cortical screws proximally.It was reported that the distal locking screws backed out.The surgeon removed the va lcp plate and converted to an external fixator.It is unknown if there was a surgical delay.Patient outcome was not specified.Concomitant device reported: 4.5mm ti cortex self-tapping 32mm (part number 414.832, lot unknown, quantity 1); 4.5mm ti cortex self-tapping 38mm (part number 414.838, lot unknown, quantity 2); 4.5mm ti cortex self-tapping 85mm (part number 414.885, lot unknown, quantity 1).4.5mm ti cortex screw 85mm (part number 414.085, lot unknown, quantity 1) this report is for one (1) 5.0mm variable angle locking screw/slf-tpng/strdrv/85mm.This is report 2 of 4 for (b)(4).

Manufacturer Narrative

Part: 02.231.285; lot: l943821; manufacturing site: (b)(4); release to warehouse date: june 26, 2018; expiry date: august 01, 2026.The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual and 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.The implant was received with the reported condition of ¿functional migration/backout/pull-out: rm/si.¿ please note no x-rays were provided.Flow: device interaction/functional visual inspection: the 5 mm locking screw was received at us cq with the threads on the screw head and the screw shaft stripped.These are indications that the screws were implanted and then explanted.Functional test: a functional test could not be performed as the conditions leading to backout could not be recreated at cq.The received condition does not agree with the complaint description and the complaint condition could not be replicated due to reasons stated above.Dimensional inspection: dimensional analysis was completed, the outer diameter of the screw head measured 6.75 mm.This is within specification of 6.75 mm ± 0.5.The shaft diameter measured 4.95 mm which is within specification of 4.90 to 5.05 mm.Document/specification review: the following drawing(s) was reviewed; 5.0 va locking screw slf - tpg.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.The risk management review was completed.Conclusion: the complaint condition is not confirmed as there is no x-ray showing the migration/backout/pullout of the locking screw and the complaint condition cannot be replicated.Based on the available information it is not possible to determine a definitive root cause for the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.(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.

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.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: 5.0MM VARIABLE ANGLE LOCKNG SCREW/SLF-TPNG/STRDRV/85MM
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7938431
• MDR Text Key: 122848723
• Report Number: 2939274-2018-54181
• Device Sequence Number: 1
• Product Code: JDP
• UDI-Device Identifier: 10886982062246
• UDI-Public: (01)10886982062246
• Combination Product (y/n): N
• PMA/PMN Number: K110354
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.231.285
• Device Catalogue Number: 02.231.285
• Device Lot Number: L943821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Date Manufacturer Received: 10/12/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 54