MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES

Catalog Number	03.501.033
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part: 03.501.033; lot: l776360.Manufacturing site: (b)(4).Release to warehouse date: 10.Apr.2018.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection: upon visual inspection no obvious noticeable damage was noticed near the distal threading, but the cannulation did appear to be slightly oblong, which could potentially impact its ability to thread into plates as intended, and therefore the complaint condition will conservatively be confirmed.The reported damage was not noticeable.Dimensional inspection: a 2.28mm gauge pin (gp29) was able to pass through the distal cannulation, and the drill guide drawing calls for a dimensional range of ø2.28mm to 2.35mm.Document/specification review: relevant drawing was reviewed and no product design issues or discrepancies were observed.Due to the slightly oblong cannulation, the complaint condition will be conservatively confirmed investigation conclusion: upon visual inspection no obvious noticeable damage was noticed near the distal threading, but the cannulation did appear to be slightly oblong.It is not possible to determine a definitive root cause for the complaint condition, but it is possible that not threading the guide as intended, and/or exposing it to levering forces during use, could have caused the threaded cannulated region to deform.No product design issues or discrepancies were observed.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 or Problem Description
It was reported that the threaded drill guide was discovered to have stripped out while the surgeon attempted to screw in the threaded drill guide to the matrixrib locking plate, during a thoracic procedure on an unknown date.The procedure was successfully completed using the drill sleeves in the set.It was unknown if there was a surgical delay.Patient outcome was unknown.Concomitant device reported: matrixrib plate (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 2.2mm threaded drill guide for matrixrib locking plates.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 2.2MM THREADED DRILL GUIDE FOR MATRIXRIB LOCKING PLATES
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7973823
• Report Number: 2939274-2018-54421
• Device Sequence Number: 19252908
• Product Code: FZX
• UDI-Device Identifier: 10887587010649
• UDI-Public: (01)10887587010649
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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: 03.501.033
• Device Lot Number: L776360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1