MAUDE Adverse Event Report: SYNTHES USA DHS®/DCS® GUIDE SHAFT WITH FLATS

Catalog Number 338.23

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Failure of Implant (1924); Sedation (2368)

Event Date 12/26/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on (b)(6) 2005, during open reduction internal fixation (orif) of a hip, a guide shaft stripped while inserting a lag screw.The end of the lag screw then became deformed and the dynamic hip screw (dhs) plate could not be inserted over it.A wrench was used to remove it, but was then stuck on the lag screw.A second set was opened to put a new lag screw in and the procedure was completed.The same plate was used.There was a 30 minute delay.There were no fragments left in the patient.The patient status outcome is unknown.The surgery was successfully completed.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Additional narrative: device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).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.

Manufacturer Narrative

Product investigation summary: the following complaint devices were received for evaluation: one dhs/dcs guide shaft with flats (part 338.23 / lot number unknown); one dhs.Dcs lag screw 12.7mm thread/85mm (part 280.850 / lot number 7082641); one dhs/dcs wrench (part 338.06 / lot number 1070); the returned instruments are used in the dhs/dcs dynamic hip and condylar screw system (technique guide j3045-g).The complaint condition for the dhs/dcs guide shaft was likely caused by the use of the excessive torque during surgery; however, this complaint is not likely a result of any design related deficiency.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.

• Brand Name: DHS®/DCS® GUIDE SHAFT WITH FLATS
• Type of Device: GUIDE
• 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: 5365184
• MDR Text Key: 35917153
• Report Number: 2520274-2016-10213
• Device Sequence Number: 1
• Product Code: FZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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,Followup,Followup
• Report Date: 12/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 50 YR
• Patient Weight: 63