MAUDE Adverse Event Report: SYNTHES HAGENDORF 17.0MM/3.2MM WIRE GUIDE 161MM

Catalog Number 357.392

Device Problems Fitting Problem (2183); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2015

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Implant and explant dates: device is an instrument and is not implanted or explanted.The complainant part has not been returned for manufacturer review/investigation.Initial reporter: hospital contact number: (b)(6).The investigation could not be completed; no conclusion could be drawn as no product was received.Device history review: manufacturing location: (b)(4) - manufacturing date: november 27, 2012 no anomalies were detected during device history record review.No non-conformance reports were generated during production.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.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.

Event Description

Device report from synthes (b)(6) reports an event as follows: it was reported that surgical staff could not pass the guide wire down the sleeve from a trochanteric fixation nail (tfn) set during a pre-operative safety screening.In addition, it was reported that there was something impeding inside the sleeve that stopped the guide wire from advancing.The surgical procedure was successfully completed with a back-up wire sleeve.No surgical delay was reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

Additional narrative: product investigation summary: the complaint condition for the 17.0mm/3.2mm wire guide (part 357.392 / lot 8135206) was likely caused by the application of excessive force to the device; however, this complaint is not likely a result of any design related deficiency.The 17.0mm/3.2mm wire guide is an instrument routinely used in the titanium trochanteric fixation nail system.The device was returned and reported that a guide wire would not pass through the cannulation during surgery.This condition is confirmed; a 3.2mm gauge pin would not pass through the cannulation of the wire guide.The distal portion of the device shows markings from hammer strikes.It is likely that excessive force was applied to the device, which has led to this complaint condition.The device was manufactured in november, 2012 and is over two years old.The balance of the returned device is in fair condition with some signs of wear at the distal and proximal ends.The associated drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.It is likely that excessive force was applied to the device, which has led to this 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: 17.0MM/3.2MM WIRE GUIDE 161MM
• Type of Device: GUIDE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5070366
• MDR Text Key: 25538624
• Report Number: 3003875359-2015-10392
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 357.392
• Device Lot Number: 8135206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2012
• 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