MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM HEADLESS COMPRESSION SCREW-LONG THREAD 20MM; SCREW, FIXATION, BONE

Model Number	02.226.120
Medical Device Problem Codes	Failure to Cut (2587); Difficult to Advance (2920)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/07/2019
Type of Reportable Event	Serious Injury
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.(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 or Problem Description
It was reported that on during on an unknown procedure (b)(6) 2019, the long thread of the headless compression screw did not engage in the near cortex.The head would not advance into the bone and was still in the joint.The surgeon removed the screw and used a non-synthes headless screw to complete the surgery.In addition, it was reported that the silicone handle broke into two pieces.Procedure was successfully completed with a surgical delay of twenty to thirty (20-30) minutes.There was no patient harm.This report is for a 3.0mm headless compression screw.This is report 1 of 2 for (b)(4).

• Brand Name: 3.0MM HEADLESS COMPRESSION SCREW-LONG THREAD 20MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8760845
• Report Number: 2939274-2019-59027
• Device Sequence Number: 19204674
• Product Code: HWC
• UDI-Device Identifier: 10886982058263
• UDI-Public: (01)10886982058263
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2019

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
• Operator of Device: Health Professional
• Device Model Number: 02.226.120
• Device Catalogue Number: 02.226.120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 07/03/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention