MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST

Catalog Number	310.243
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(b)(4).Product was not returned and without a lot number the device history records review could not be completed; the investigation could not be completed; no conclusion could be drawn.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a guide wire was bent and stuck between the lid and the case in an evaluation set.There is no patient or procedure involved.No additional information is available.This complaint involves one (1) device.(b)(4).

• Brand Name: GUIDEWIRE Ø2.5 W/DRILL TIP L200 SST
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7336570
• Report Number: 2939274-2018-51043
• Device Sequence Number: 10925219
• Product Code: FZX
• UDI-Device Identifier: 10886982186300
• UDI-Public: (01)10886982186300(10)LOTNUMBERUNK
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 310.243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1