MAUDE Adverse Event Report: SYNTHES (USA) 1.6MM THREADED GUIDE WIRE 150MM¿STERILE; WIRE, SURGICAL

Catalog Number 292.720S

Device Problems Sticking (1597); Mechanical Jam (2983)

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

Event Date 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product code is jdw.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 surgery, the 1.6mm k-wire could not be removed from the guide hole of the insertion guide.The surgeon had inserted the k-wire into the guide hole of the insertion guide to confirm the plate was in the correct position.However, the surgeon was not able to pull the k-wire out after insertion.The surgery was delayed 10 minutes due to the reported event.There was no patient harm.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.

Manufacturer Narrative

An investigation summary was performed ¿ a manufacturing conclusion cannot be presented because of the condition of the product.The broken off portion of a 1.6mm k-wire with unknown lot number is blocked in the location bore of the philos aim-device.The visible portion of the k-wire of approx.4mm shows various marks and deformation; hence the dimensions are not verifiable to the valid specifications anymore.Visually there does not appear to be an issue other than the damage sustained by mechanical overloading.This complaint is deemed indeterminate from a manufacturing standpoint.(b)(4).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: 1.6MM THREADED GUIDE WIRE 150MM¿STERILE
• Type of Device: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5042699
• MDR Text Key: 24659431
• Report Number: 2520274-2015-15586
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMENDMEN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.720S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1