MAUDE Adverse Event Report: SYNTHES HAGENDORF 1.0MM CERCLAGE WIRE COILS 10 METERS; CERCLAGE FIXATION

Catalog Number 291.050

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(6).The patient¿s exact age is unknown.The description of event(s) indicated that the patient was over 80 years old; however, the x-ray images received seem to indicate the patient was (b)(6).The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: june 28, 2011.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent revision on (b)(6) 2016 due to reports of pain and wire breakage.The patient was originally treated for a fractured right patella via fixation on (b)(6) 2015.On an unknown date, the patient reportedly began experiencing pain.X-rays captured on (b)(6) 2016 identified breakage of the implanted cerclage wire coil.The issue was addressed during the revision procedure; however, additional information pertaining to the outcome of that procedure is unknown.This report is 1 of 1 for (b)(4).

• Brand Name: 1.0MM CERCLAGE WIRE COILS 10 METERS
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5993743
• MDR Text Key: 56331835
• Report Number: 3003875359-2016-10529
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2016

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 Catalogue Number: 291.050
• Device Lot Number: 7510465
• Other Device ID Number: (01)07611819013483(10)7510465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention