MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE EX-FIX ROD ATTCHMT/MULTI PIN CLAMP/MR-CONDITIONAL; APPLIANCE,FIXATION,NAIL

Model Number 390.003

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The device was received, the investigation is in progress, 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 an unknown date, there were (2) separate incidents when the clamp part of the multi-pin clamp and attachment did not completely stop when tightening the carbon fiber rod.The surgeons had to remove the ex-fix after they achieved reduction.They replaced the clamps then had to attempt the reduction again.It is unknown if there was a surgical delay.Procedure and patient outcome are unknown.Concomitant devices reported: unknown carbon fiber rod (part# unknown, lot# unknown, quantity# 1).This report is for one (1) large ex-fix rod attchmt/multi pin clamp/mr-conditional.This is report 2 of 2 for (b)(4).This complaint captures the first event while (b)(4) captures the second event.

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.Part 390.003; lot: h794433; date of manufacture: january 22, 2019; place of manufacture: brandywine plant; part expiration date: n/a (nonsterile).The device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition.Visual inspection: the rod attachment was received at the us customer quality (cq) affixed to a multi-pin clamp.No components are missing, but the device is not functioning as intended.The rod clamp subcomponent is not able to rotate from within the post clamp subcomponent.No other issue could be identified with the returned portions of the device.Functional test: a functional test was performed on the rod attachment.The rod clamp bolt subcomponent is able to loosen and tighten the rod clamp subcomponent.The post clamp bolt subcomponent is seized in a tightened position, preventing the rod clamp from rotating within the post clamp subcomponent.Due to a lack of appropriately sized rods, the grip strength of the rod clamp was not tested.The complaint cannot be replicated with the returned devices.Dimensional inspection: a dimensional inspection was not able to be performed due to the received condition.Document/specification review: drawings reviewed (current & manufactured revision): rod attachment.Mr conditional.Post clamp multi-pin clamp, mr conditional.Post clamp bolt multi-pin clamp, mr conditional.Rod clamp multi-pin clamp, mr ocnditional.Rod clamp bolt multi-pin clamp, mr conditional.Device history: the received device was manufactured at the brandywine site on january 22.2019.The device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition.Conclusion: the complaint is not confirmed for the rod attachment.The rod clamp is able to tighten and loosen as it is intended to function, however the post clamp bolt is seized in a tightened position, preventing the rod clamp from rotating as it is intended to function.The device is not ¿loose¿ as it is coded, but it is seized.The clamping ability of the device was not tested.There is no indication that a design or manufacturing issue contributed to the complaint.No definitive root cause could be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: LARGE EX-FIX ROD ATTCHMT/MULTI PIN CLAMP/MR-CONDITIONAL
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8601250
• MDR Text Key: 144746481
• Report Number: 2939274-2019-57968
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982197801
• UDI-Public: (01)10886982197801
• Combination Product (y/n): N
• PMA/PMN Number: K122455
• 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: 04/15/2019

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: 390.003
• Device Catalogue Number: 390.003
• Device Lot Number: H794433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/30/2019
• Supplement Dates FDA Received: 06/10/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention