MAUDE Adverse Event Report: SYNTHES BALSTHAL 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM; NAIL,FIXATION,BONE

Catalog Number 292.699

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

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.(b)(4).Manufacturing date: 22 february 2016.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: i was reported during an unknown procedure on (b)(6) 2016, a 2.0mm kirschner wire with threaded spade point tip broke off and remains embedded in patient¿s femur.Procedure was completed successfully with no delay.This report is for one (1) 2.0mm kirschner wire with treaded spade point tip.(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (2.0mm kirschner wire threaded spade point tip 280mm, part number 292.699, lot number 9849002).The subject device was returned with the complaint condition stating: received condition: the k-wire ø2 thread-tip l280 sst has been received with the entire threaded tip broken off.The broken off portion measuring approximately 20 mm is not available for investigation.The device is slightly bent.There are severe striations and marks on a length of approximately 24 mm located right after the fracture surface and some minor striations located at various areas on the entire k-wire shaft.Almost the entire etch therefore has disappeared; only the first four numbers of the lot are readable but they are conforming to the reported lot number 9849002.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 referring to the actual technical drawing and found to meet the specifications.Target dimension of shaft outside diameter 2.00 +0/- 0.03 mm.Actual dimension of shaft outside diameter 1.98 mm / pass.Conclusion: a final manufacturing conclusion cannot be presented because of the condition of the product and the received poor clinical information.The various marks and striations especially at the area close to the breakage point to the fact that the device was subjected to forcible use.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM
• Type of Device: NAIL,FIXATION,BONE
• 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: 6634314
• MDR Text Key: 77521325
• Report Number: 3009450863-2017-10014
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07611819221802
• UDI-Public: (01)07611819221802(10)9849002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962047
• 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: 05/15/2017

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: 292.699
• Device Lot Number: 9849002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1