MAUDE Adverse Event Report: SYNTHES USA 1.7MM CABLE WITH CRIMP 750MM-STERILE; CERCLAGE FIXATION

Catalog Number 298.801.01S

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This report is for unknown screw locking 7.3/unknown lot number.Device is not expected to be returned for manufacturer review/investigation.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient was brought to the operating room on (b)(6) 2015 to revise a plate/screw construct that was originally implanted roughly two weeks prior to (b)(6) 2015 (the hospital was unaware of the original date of surgery as it occurred at a different facility).The revision was due to malunion/loss of reduction (the comminuted fracture fell apart).The synthes hardware was intact; however, it looked like the osteopenic nature of the patient's bones caused the need for revision surgery.The plate and screws were removed, the fracture was reduced, and a trochanteric fixation nail (tfn) was placed (concomitant device 1.7mm cable).The surgery was successfully completed with no surgical delay.This report is 4 of 5 for (b)(4).

• Brand Name: 1.7MM CABLE WITH CRIMP 750MM-STERILE
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5237935
• MDR Text Key: 31671367
• Report Number: 2520274-2015-17431
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 298.801.01S
• Other Device ID Number: UDI: (01)10886982182500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR