MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, SHORT; SCREWDRIVERS

Model Number	314.67
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.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.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
Device report from synthes (b)(4) reports an event as follows: it was reported that on (b)(6) 2019, a screwdriver shaft cruciform with holding sleeve was broken when removing a 2.0 screw during an orthopedic procedure.It was a screw removal case as fracture was healed.There was no fragment generated.The procedure was successfully completed with no surgical delay reported.There was no patient consequence.Concomitant device reported: 2.0 screw (part/lot unknown, quantity 1).This report is for a screwdriver shaft.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM/2.0MM SCREWDRIVER BLADE WITH HOLDING SLEEVE, SHORT
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8587241
• Report Number: 2939274-2019-57875
• Device Sequence Number: 16528216
• Product Code: HXX
• UDI-Device Identifier: 10887587037592
• UDI-Public: (01)10887587037592
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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: 314.67
• Device Catalogue Number: 314.67
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1