MAUDE Adverse Event Report: SYNTHES BALSTHAL 1.25MM THREADED GUIDE WIRE 150MM; WIRE, SURGICAL

Catalog Number 292.620

Device Problems Break (1069); Material Fragmentation (1261)

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

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information is not available for reporting.Additional device product code: hty.Implant and explant dates: device broke intra-operatively, partial device remained in the patient.Device was not fully implanted or explanted.Initial reporter telephone number: (b)(6).A device history record (dhr) review was performed for part # 292.620, lot # 9931569: manufacturing location: (b)(4), manufacturing date: 25 april 2016: no non conformance reports (ncrs) were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The device has been 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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during an unknown surgery performed on (b)(6) 2016, the surgeon discovered that the tip of the 1.25mm stainless steel guide pin broke off after drilling through the medial malleolus.The length of the broken tip was around 4 to 5mm under screening.Operation was proceeding and the surgeons decided to leave the broken tip in the bone.No any surgical intervention was required after the operation.Surgery was completed successfully.No surgical delay reported.No information about patient status.This report is for one (1) 1.25mm threaded guide wire 150mm.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product development investigation was completed.Received condition: the guidewire ø1.25 w/thread-tip w/trocar l150 has been received with the entire threaded tip broken off.The broken off portion measuring approximately 5 mm is not available for investigation.The device is slightly bent.There are visible slight striations on the remaining shaft.Dimension: because of the missing front portion the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.The remaining shaft diameter was measured and found to meet the specifications.Target dimension of shaft outside diameter 1.25 +0/- 0.07 mm; actual dimension of shaft outside diameter 1.23 mm / pass.Dhr review: the manufacturing documents were reviewed and no complaint related issues were found.This device was manufactured with a lot size of 266 pieces in march 2016.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition and the correct material 1.4112 / iso 5832-1/d stainless steel was used.Conclusion: a final manufacturing conclusion cannot be presented because of the condition of the product and the received poor clinical information.We determine that the most probable root cause is excessive force through the method of use and associated accumulated damage and wear.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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6663682
• MDR Text Key: 78475020
• Report Number: 3009450863-2017-10018
• Device Sequence Number: 1
• Product Code: LRN
• UDI-Device Identifier: 07611819013841
• UDI-Public: (01)07611819013841(10)9931569
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620
• Device Lot Number: 9931569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1