MAUDE Adverse Event Report: SYNTHES USA; WIRE,SURGICAL

Device Problems Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reportedly there was no patient involvement.This report is for an unknown k-wire/unknown lot.Part and lot number are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Contact phone number: (b)(6).Without a lot number the device history records review could not be completed.A product investigation was completed: a visual inspection under 5x magnification, functional test, drawing review, and dimensional analysis were performed as part of this investigation.A definitive root cause cannot be identified with the limited complaint details.No new, unique or different patient harms were identified as a result of this evaluation.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.A k-wire was returned stuck in part 310.221, lot f-17409.The two devices could not be separated to determine the relevant dimension of both parts or the part number of the guidewires.The guidewires did not appear to be broken and the drill bit showed minimal signs of wear.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 europe reports an event in (b)(6) as follows: it was reported that parts were detected as damaged during internal inspection of loaner kits.Reportedly there was no patient or procedure involvement.This report is for a k-wire which reportedly did not fit with other parts.When the device was received, it was noted that the device was stuck in the cannulation of part 310.221 / lot f17409.This report is for an unknown k-wire.This report is for (b)(4).

• Type of Device: WIRE,SURGICAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6752011
• MDR Text Key: 81568177
• Report Number: 2520274-2017-11999
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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