MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED STARDRIVE SCREWDRIVER T15; SCREWDRIVERS

Catalog Number	03.226.041
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 during an unknown foot surgery on (b)(6) 2017, a screwdriver tip broke during implantation of a screw.The broken pieces were removed successfully.There was no patient harm or surgical time delay reported.This is all the information available.Concomitant device reported: cannulated screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) cannulated stardrive screwdriver t15.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Initial reporter is synthes sales consultant.Dhr review was completed.Part no.: 03.226.041, lot no.: 9098264, manufacturing location: (b)(4), release to warehouse date: 08.Sep.2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.The returned screwdriver was confirmed to have a broken tip.The broken tip was not returned.Replication of the complaint condition is not applicable as the device is already broken.No additional malfunctions were observed during investigation.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product including material and material properties that would contribute to this complaint condition.The drawings were reviewed during investigation.The inner diameter of the tip was measured to be 1.73mm which is within the specification of 1.7mm +0.05/-0.Measured using vermont gage pin no definitive root cause was able to be determined.It is likely that the screwdriver tip experienced excessive force.There were no issues during the manufacture of this product that would contribute to this complaint condition.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 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.

• Brand Name: CANNULATED STARDRIVE SCREWDRIVER T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7176798
• Report Number: 2939274-2018-50141
• Device Sequence Number: 11114582
• Product Code: HXX
• UDI-Device Identifier: 10886982077172
• UDI-Public: (01)10886982077172(10)9098264
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 03.226.041
• Device Lot Number: 9098264
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/26/2017
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR