MAUDE Adverse Event Report: SYNTHES BRANDYWINE 4.5MM THREADED CERCLAGE POSITIONING PIN; CERCLAGE FIXATION

Catalog Number 298.803Y

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Report is for four (4) unknown positioning pins.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received (b)(4) capture patient¿s revision procedure.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

It was reported that a patient was revised to a competitor's plate after removal of a 4.5mm va-lcp condylar plate and screws.The original implant surgery took place (b)(6) 2015.The initial fracture was a mid-shaft femoral fracture that was distal to the stem.The patient reported pain and upon x-ray review it was determined the plate broke around a screw hole and resulted in a re-fracture.The revision surgery took place on (b)(6) 2015 with all hardware removed; inclusive of the va-lcp condlyar plate, four (4) positioning pins and unknown number of screws.There was no surgical delay or fragments generated from the breakage.This report is for four (4) unknown positioning pins.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Product investigation summary: the following device(s) were received: 4.5mm va-lcp curved condylar plate (part 02.124.418 | lot 8750572).Cerclage positioning pins, threaded (part 298.803 | lot 7376020) - qty: (b)(4).Cerclage positioning pins, threaded (part 298.803 | lot 7816611) - qty: (b)(4).5.0mm periprosthetic va locking screw (part 02.231.010 | lot 7792387) - qty: (b)(4).A total of six (6) implants were received.The plate is broken into two pieces at the sixth and seventh combi holes proximal to the condylar head portion of the plate.There are numerous scratches and discolorations on the plate consistent with it being implanted.The remaining devices (one screw and four cerclage positioning pins) are locked into the plate and show minor cosmetic scratches and wear.These devices are functionally undamaged and did not contribute to the complaint condition.Although the exact cause for the complaint condition cannot be determined, it is likely that excessive, cyclic loading due to insufficient/delayed bone healing resulted in the plate bearing the entire functional load of the patient.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Device history record review: manufacturing location: (b)(4).No non-conformance reports 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 condition.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.

Event Description

This report is 3 of 6 for (b)(4).

• Brand Name: 4.5MM THREADED CERCLAGE POSITIONING PIN
• Type of Device: CERCLAGE FIXATION
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5153623
• MDR Text Key: 28435911
• Report Number: 2520274-2015-16688
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 298.803Y
• Device Lot Number: 7816611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 59