MAUDE Adverse Event Report: SYNTHES HAGENDORF CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS

Catalog Number 03.010.000

Device Problem Fitting Problem (2183)

Patient Problem Sedation (2368)

Event Date 11/19/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the expert tibial nail was inserted in (b)(6) 2013.During a nail removal operation, extraction screw in question was not connected to the nail.As instructed in the guide, the surgeon had removed the end caps and all the locking screws except one screw and also removed the bone fragment in the connecting part of the nail and extraction screw.Eventually, the surgeon closed the surgical incision without removing the nail and the operation finished with 60 minutes of delay.This is 1 of 2 reports for (b)(4).

Manufacturer Narrative

Device used for treatment not diagnosis.Instrument; not explanted or implanted.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The part was not returned for evaluation.No conclusion could be drawn, as the part was not received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONICAL EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• Type of Device: EXTRACTION
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4366829
• MDR Text Key: 5264187
• Report Number: 3003875359-2014-10437
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/02/2014

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: 03.010.000
• Device Lot Number: 3398117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2010
• 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: 33 YR