MAUDE Adverse Event Report: SYNTHES USA; BOLT, NUT, WASHER

Device Problems Separation Failure (2547); Device Operates Differently Than Expected (2913)

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

Event Date 07/27/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown bolts/unknown lot numbers.Implant date may be (b)(6), 2015, not confirmed.Explant date: not explanted.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 a connection bolt would not disconnect from a nail at the end of a tfna procedure.The surgeon cranked on it as hard as he could and finally it released.This caused an approximate 10 minute surgical delay, and one extra xray was taken.The procedure was completed without further incident.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

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.

• Type of Device: BOLT, NUT, WASHER
• 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: 5002703
• MDR Text Key: 22950504
• Report Number: 2520274-2015-15226
• Device Sequence Number: 1
• Product Code: HTN
• 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
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• 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