MAUDE Adverse Event Report: SYNTHES (USA); CERCLAGE, FIXATION

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown cerclage cable.Part and lot numbers were not available for reporting.Other number¿udi: unknown part number, udi is unavailable.Pending completion.This device is not considered to have been implanted/explanted.Since a fragment of the implant was found within the reported and returned cable tensioner, this device was considered to have broken intraoperatively.The subject device has been received and is currently undergoing investigation; the results are pending completion.Without a lot number the device history records review could not be completed.Date of manufacture is unknown.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 initially reported that during an open reduction internal fixation (orif) procedure of the right femur on (b)(6) 2016, while the surgeon was applying tension to the third cable using the cable tensioner instrument, he noted that the instrument was not applying enough pressure to the cable for proper fixation.The surgeon chose another tensioner instrument that was available in the operating room to complete the surgery.Due to this event an additional 10 minutes was added to operating room time.The surgery was completed successfully and patient is reported in stable condition.This event was initially determined to be non-reportable.The devices were returned to the synthes manufacturer for investigation.Upon visual instrument inspection by quality engineer on november 7, 2016, it was noted that a fragment of cable implant was inside the tensioner instrument.The event was re-evaluated based on this finding and was determined to be reportable.This report is for one unknown cerclage cable.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the cable tensioner (part number 391.201, lot number p308325) and unknown cable fragment (part/lot number unknown).The subject device was returned to the supplier (b)(4) with the complaint condition stating the visual inspection confirmed a piece of cable caught in the chuck jaws of the tensioner.The device was sent to instrument assembly where the cable piece was removed.Following removal of the cable piece the inner assembly was inspected.Inspection results observed that the tensioner meets manufacturing specifications and functions as intended.The complaint condition (tensioner not applying enough force) was unable to be replicated by the supplier as the device was found to be within specification.As the complaint was unable to be replicated and no defects or deficiencies were identified with the returned part, no further investigation including a drawing review, root cause analysis, and risk assessment is necessary.The complaint is unconfirmed.There was no further information reported on the wire as the circumstance that lead to the breakage are unknown.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No root cause was identified as the complaint condition was unable to be confirmed by the supplier.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: CERCLAGE, FIXATION
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6136200
• MDR Text Key: 61190789
• Report Number: 2520274-2016-15531
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR