MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW; ROD,FIXATION,INTRAMEDULLARY

Model Number	03.033.006
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Reporter is synthes sales consultant.A device history record (dhr) review was conducted for part: 03.033.006, lot: l699644: manufacturing site: (b)(4), release to warehouse date: 16.Mar.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 functional, visual and packaging 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: the distal thread form was found to be stripped and the thread was displaced to the gap between the two thread peaks.The observed condition may lead to the reported condition of difficult to remove from the nail; therefore, it agrees with the reported condition.The nail was not returned.Drawing/specification review: the relevant drawings were reviewed during investigation dimensional inspection: the major diameter of the non-deformed section of the thread measured and is within the specification per relevant drawing.No definitive root cause was able to be determined, however it is possible that the threads were cross threaded with the nail.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 on an unknown date, patient underwent an unknown procedure.At the end of the procedure, the cannulated connecting screw was difficult to remove from the nail.There was no patient consequence reported.It is unknown if there was a surgical delay.Patient and procedure outcome were unknown.Concomitant device reported: unknown nail (part# unknown, lot# unknown, quantity# 1).This is report 1 of 1 for complaint (b)(4).

• Brand Name: CANNULATED CONNECTING SCREW
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7898778
• Report Number: 2939274-2018-53907
• Device Sequence Number: 1434457
• Product Code: HSB
• UDI-Device Identifier: 10886982271105
• UDI-Public: (01)10886982271105
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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 Model Number: 03.033.006
• Device Catalogue Number: 03.033.006
• Device Lot Number: L699644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1