MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW SHORT THREAD/42MM; SCREW, FIXATION, BONE

Model Number	207.642
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Without a valid lot number the device history records review could not be completed.(b)(4).Investigation summary: complaint summary: it was reported that on (b)(4) 2021, patient underwent an orthopedic procedure, open reduction and internal fixation (orif) medial condyle (distal humerus) fracture being fixed with 4.0 cannulated screws.During insertion of cannulated screw, threads came unwound from the screw.Fragments were removed but with additional dissection, additional flouroscopy time, additional tourniquet time, additional anesthesia time, and procedure time with a surgical delay of 40 minutes.The procedure was completed successfully.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves one (1) device.Photo investigation: the device was not returned.A photo-investigation was performed based on all the images/x-rays located under pc attachments received at (b)(6) 2021.Upon inspecting all the photos/x-rays provided, the thread/s of cannulated screw was observed to be peeled out from the screw.The root cause of the broken thread/s cannot be confirmed based on the provided photos/x-rays.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : a manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.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 (b)(6) 2021, patient underwent an orthopedic procedure, open reduction and internal fixation (orif) medial condyle (distal humerus) fracture being fixed with 4.0 cannulated screws.During insertion of cannulated screw, threads came unwound from the screw.Fragments were removed but with additional dissection, additional flouroscopy time, additional tourniquet time, additional anesthesia time, and procedure time with a surgical delay of 40 minutes.The procedure was completed successfully.Concomitant device reported: unknown screwdriver (part# unknown; lot# unknown; quantity: 1).This complaint involves one (1) device.

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/42MM
• 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: 11897602
• Report Number: 2939274-2021-02655
• Device Sequence Number: 14340387
• Product Code: HWC
• UDI-Device Identifier: 10886982148254
• UDI-Public: (01)10886982148254
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: PREADM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 207.642
• Device Catalogue Number: 207.642
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 49