MAUDE Adverse Event Report: SYNTHES HAGENDORF EXTRACTSCR F/A2FN; EXTRACTOR

Catalog Number 03.010.373

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.(b)(6).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: sep 24, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that during a planned removal of an antegrade femoral nail (b)(4) (afnj) on (b)(6) 2017, the surgeon couldn¿t connect the nail with an extraction screw and decided leaving the nail inside the patient.As a test the surgeon attempted to connect another nail with the extracting screw after the surgery and he was only able to connect a little (only 1.5 or 2 rotations) indicating that the issue was with the extraction screw instrument and not the afnj.There was no allegation of complaint against the afnj implant.The afnj was initially implanted on an unknown date to treat a femoral shaft fracture.The procedure was not successfully completed as the implant was left in patient.There was no information reported regarding surgical delay due to the reported event.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (extractscr f/a2fn, part number 03.010.373, lot number 9559829).The subject device was returned with the complaint condition stating: visual investigation shows clearly that the connecting thread at the tip is damaged.The flanks are scrunched and therefore it was not possible to connect them with the nail.We have to reasonably conclude that the thread of the extraction screw was not properly aligned to the nail and therefore was damaged during use while applying torsional force.As result of the damaged thread, it is not possible to measure the exact dimensions anymore.Based on the provided information we are not able to determine the exact cause of this complaint.Excessive force, not fully seating the extraction screw to the nail or normal wear and tear could lead to the complained issue.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACTSCR F/A2FN
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6425276
• MDR Text Key: 70624847
• Report Number: 3003875359-2017-10135
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819327009
• UDI-Public: (01)07611819327009(10)9559829
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

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: 03.010.373
• Device Lot Number: 9559829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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: 17 YR