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 Device Embedded In Tissue or Plaque (3165)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product code is hty.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.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 an unspecified surgery the guide wire broke while it was being removed from the patient using an unknown competitor¿s instrument with a wire driver attachment.Fragments were generated and were unable to be removed from the patient.The surgery was completed successfully and the patient was reportedly fine postoperatively.There was no report of surgical delay due to the reported event.Concomitant medical products: unknown competitor¿s instrument with wire driver attachment (part# unknown / lot# unknown / quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: lot number device returned may 22, 2017.Dhr review was conducted: no ncr's 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.Manufacturing location: (b)(4) manufacturing date: 23 september 2016.A manufacturer's evaluation was conducted: 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 severe striations and marks on a length of approximately 20 mm located at approximately 60 mm and some minor striations located at approximately 20 mm from the broken off tip.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 with caliper ref.(b)(4) referring to the actual technical drawing (b)(4) version a and found to meet the specifications.Target dimension of shaft outside diameter 1.25 +0/- 0.07 mm actual dimension of shaft outside diameter 1.24 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 (b)(4) pieces in september 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.Dcrm review: the wires (power driven) - core dossier design and clinical risk management (dcrm) document, (b)(4), rev.A.6, was reviewed and found to adequately address the harm of this complaint condition.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.No manufacturing related issue was identified and/or confirmed therefore no corrective/preventive action is required.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: 1.25MM THREADED GUIDE WIRE 150MM
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal NY CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal NY CH471 0; SZ CH4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6553320
• MDR Text Key: 74698250
• Report Number: 3003506883-2017-10073
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMEND
• 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: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.620
• Device Lot Number: L148117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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