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

Catalog Number 357.133

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 357.133, lot# 1772059.Manufacturing location: (b)(4), manufacturing date: nov 14, 2007.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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.

Event Description

It was reported that during the routine inspection, the extraction screw was found to be stripped (threaded part was stripped).There was no patient involvement.This report is for one (1) extraction screw.This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Additional narrative: a product development investigation was performed on the returned device (extraction screw for ti femoral and tibial nails, part # 357.133, lot # 1772059).This complaint is confirmed.The extraction screw was received intact but with the distal tip damaged / stripped.The threads show wear and flattening.The damage on the returned 9 year old reusable extraction screw is consistent with cross threading.Per the technique guide, bony ingrowth and tissue must be removed from the end of nail prior to inserting the extraction screw into the nail and the nail is to be extracted using ¿gentle blows with the hammer.¿ whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already damaged.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The returned extraction screw for ti femoral and tibial nails is an instrument used to extract femoral and tibial nails during explantation.Drawing was reviewed during this evaluation.No product design issues or discrepancies were observed.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: EXTRACTION SCREW FOR TI FEMORAL AND TIBIAL NAILS
• 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: 6216000
• MDR Text Key: 63657233
• Report Number: 3003875359-2016-10676
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982195883
• UDI-Public: (01)10886982195883(10)1772059
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.133
• Device Lot Number: 1772059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2007
• 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