MAUDE Adverse Event Report: SYNTHES USA DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.310

Device Problem Failure to Align (2522)

Patient Problem Sedation (2368)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: the wrench broke during surgery.The surgeon started by using a one-step technique, but changed this during surgery and disconnected the wrenches from the dynamic hip screw.When he wanted to put this assembly back together he had difficulties getting it to fit.He hammered one of the wrenches when he tried to get the plate into the hole he had just reamed.The plate was hitting against the bone instead of the hole and excessive force was used and the wrench broke.It was reported there was a forty-five minute delay in the procedure.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Exact age and/or date of birth is unknown.Patient is reported as elderly.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.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.

• Brand Name: DHS®/DCS® COUPLING SCREW
• Type of Device: EXTRACTOR
• 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: 4336050
• MDR Text Key: 5178830
• Report Number: 2520274-2014-15416
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention