MAUDE Adverse Event Report: SYNTHES USA STARDRIVE SCREWDRIVER SHAFT T8105MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number 314.467

Device Problem Material Deformation (2976)

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

Event Date 06/12/2016

Event Type  malfunction  

Manufacturer Narrative

This device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.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.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 during an initial surgery for an open reduction internal fixation (orif) for a distal tibia fibula fracture, the surgeon over torqued the stardrive screwdriver shaft and the tip became twisted.The surgeon used another stardrive screwdriver shaft and again the tip also became twisted during use.Another set was available and surgery was completed successfully.There was no harm to patient and no surgical delay reported.This report is 1 of 2 for (b)(4).

• Brand Name: STARDRIVE SCREWDRIVER SHAFT T8105MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• 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: 5762233
• MDR Text Key: 48563339
• Report Number: 2520274-2016-13332
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK152239
• 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
• Report Date: 06/17/2016

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
• Device Catalogue Number: 314.467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 06/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1