MAUDE Adverse Event Report: SYNTHES BALSTHAL 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM; WIRE,SURGICAL

Catalog Number 292.160.10

Device Problem Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: a product development evaluation and a manufacturing evaluation were completed: the 19 k-wires were returned in a damaged state with varying amounts of scratches.(b)(4) parts showed no damage at all.(b)(4) parts showed minimal damage, which may be the result of a normal use.(b)(4) parts were heavily damaged.The colibri device mentioned in the complaint was not provided.The heavily damaged k-wires suggest that these parts were misused.Wrong power tool clamping setting, not enough manual pressure or multiple use of these single-use items are most likely.It is mentioned in the complaint that k-wires and tools of multiple companies are being used at this site.Without knowledge of which instrument was used with which k-wire a closer investigation is not possible.Further investigation regarding the manufacturing and raw material documents shows conformity to the specification as well.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 there was a problem with the quick coupling getting metal particles after cleaning.The product was used with both synthes and non-synthes k-wires.The non-synthes companies are also being contacted about the issue.There was no patient involvement.This is report 10 of 20 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The aware date for this report reflects the date the additional (b)(4) parts were received by synthes as part of the existing complaint received on (b)(4) 2014.Additional common device name: hty.No nonconformance 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.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH47 10; SZ CH4710
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3942686
• MDR Text Key: 11951503
• Report Number: 3009450863-2014-10022
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.160.10
• Device Lot Number: 8331600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1