MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW-SHORT THREAD 58MM; SCREW, FIXATION, BONE

Model Number	207.658
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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
It was reported that on an unknown date, the 2.7mm variable angle locking screws would not lock into the fourth most proximal hole of the 2.7mm/3.5mm variable angle lcp posterolateral distal humerus plates with lateral support.Both implants remained in the patient.The 4.0mm cannulated screw short and 4.0mm cannulated screw short thread 64mm were stripped or the cannulated hex screwdriver was stripped.A second set for another screwdriver was opened and the handle broke.Both screws remained in the patient.There was ten (10) minutes of surgical delay.The procedure outcome is unknown.The patient outcome was good.This report involves one (1) 4.0mm cannulated screw-short thread 58mm.This is report 2 of 6 for (b)(4).

• Brand Name: 4.0MM CANNULATED SCREW-SHORT THREAD 58MM
• 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: 11760211
• Report Number: 2939274-2021-02186
• Device Sequence Number: 3142722
• Product Code: HWC
• UDI-Device Identifier: 10886982148339
• UDI-Public: (01)10886982148339
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• 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): 04/07/2021

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: 207.658
• Device Catalogue Number: 207.658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1
• Patient Age: 49 YR