MAUDE Adverse Event Report: SYNTHES USA; CERCLAGE FIXATION

Device Problems Bent (1059); Mechanical Jam (2983)

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

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is unknown.This report is for an unknown cable/unknown lot.Part and lot numbers are unknown; udi number is unknown.It is unknown if the cable that was stuck was the same cable that was implanted or if a different cable was implanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation (orif) of acromion procedure, the surgeon fed a bent cable into the tensioner.This got stuck and could not be removed.Cable was tensioned by hand and crimped.The case was delayed by five (5) minutes due to the event.No adverse event to patient.This report is for an unknown cable.This is report 2 of 2 for (b)(4).

• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5694800
• MDR Text Key: 46404141
• Report Number: 2520274-2016-12993
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2016

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1