MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL HEXAGONAL SCREWDRIVER SHAFT; SCREWDRIVERS

Model Number 314.03

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

Patent identifier: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device history lot: part: 314.030, lot: 3339162, manufacturing site: (b)(4), release to warehouse date: january 11, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.(b)(4).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 Description

It was reported that on (b)(6) 2020, during a tibial plateau open reduction internal fixation (orif) while inserting a 3.5 cortex screw on power, the head of the screwdriver snapped off into the head of the screw.A medial incision was made, and the screw was backed out and removed and replaced.All fragments removed from the patient.Action taken when the event occurred medial incision to back the screw out.There was a surgical delay of 30 minutes.The procedure was successfully completed.There was no patient consequence.This complaint involves 2 devices.This report is for (1) small hexagonal screwdriver shaft.This report is 2 of 2 for (b)(4).

• Brand Name: SMALL HEXAGONAL SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11073605
• MDR Text Key: 223718036
• Report Number: 2939274-2020-05707
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188380
• UDI-Public: (01)10886982188380
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 314.03
• Device Catalogue Number: 314.03
• Device Lot Number: 3339162
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/25/2020
• Supplement Dates Manufacturer Received: 12/30/2020
• Supplement Dates FDA Received: 01/19/2021
• Patient Sequence Number: 1
• Treatment: 3.5MM CORTEX SCREW SELF-TAPPING 34MM.
• Patient Outcome(s): Required Intervention
• Patient Weight: 83