MAUDE Adverse Event Report: SYNTHES BRANDYWINE LARGE EX-FIX ROD ATTCHMT/MULTIPIN CLAMP/MR-CONDITIONAL; APPLIANCE,FIXATION,NAIL

Catalog Number 390.003

Device Problems Peeled/Delaminated (1454); Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Unknown which day the deformity of the patient¿s right leg began.Concomitant devices: carbon fiber rod (part #394.90, h133927, quantity 1), carbon fiber rod (part #394.90, lot #xxxxx27, quantity 1).(b)(4).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing location: part #390.003, lot #h280823, manufacture site: (b)(4), manufacture date: 17-jan-2017.No ncrs or scrap were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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 a patient had the placement of an external fixator of the right, distal femur and tibial plateau on (b)(6) 2017 after a self-inflicted gunshot wound to the knee.During surgical rounds the following day, a visible deformity of the patient¿s right leg was noticed and that the clamps to the fixator had slipped.An x-ray revealed that reduction was lost and the patient was brought back to the operating room the same day on (b)(6) 2017.The surgeon attempted to remove all four clamps from the carbon fiber rods but was only able to remove two of them.The two that were removed were found to be stripped.The two that were stuck on the rods were found to be tightened past the threads and were loose but unable to be detached.The patient was switched to another large external fixator and a different type of clamp was used.The remainder of the surgery was completed successfully and the patient reported as stable.The surgeon plans to perform an open reduction internal fixation (orif) of the patient¿s knee, date unknown.This complaint is for four devices.Concomitant devices: carbon fiber rod (part #394.90, h133927, quantity 1), carbon fiber rod (part #394.90, lot #xxxxx27, quantity 1).This report is 3 of 4 for (b)(4).

Manufacturer Narrative

Device 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

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

There was a ten minute delay in surgery while additional devices were obtained.

Manufacturer Narrative

Additional device product code: lxt.A product investigation was performed.This complaint is confirmed.Two clamps were received stuck on two carbon rods with the adjustment bolt unable to be tightened or loosened and two clamps were received loose in the bag with the adjustment bolt unable to be tightened or loosened.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition of post-operative loosening.The complaint condition of the adjustment bolts being stripped was able to confirmed/replicated at cq as they will not adjust (tighten or loosen).The following devices were returned as concomitant devices without an alleged complaint condition: carbon fiber rod (part #394.90, h133927, quantity 1), carbon fiber rod (part #394.90, lot #xxxxx27, quantity 1) lot number for concomitant device 394.90 is under the stuck clamp and hence was unreadable.The outside diameter for the two concomitant rods were measured at cq and found to be within specification per relevant drawing.Upon visual and dimensional inspection there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.Two clamps were received stuck on two carbon rods with the adjustment bolt unable to be tightened or loosened and two clamps were received loose with the adjustment bolt unable to be tightened or loosened.Relevant drawing was reviewed during this investigation.No product design issues or discrepancies were observed.Most likely due to surgeon over-tightening the clamps (past the thread limit) which caused the devices to loose ability to tighten or loosen.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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/MULTIPIN CLAMP/MR-CONDITIONAL
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6445759
• MDR Text Key: 71236385
• Report Number: 2530088-2017-10082
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982197801
• UDI-Public: (01)10886982197801(10)H280823
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 390.003
• Device Lot Number: H280823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 113