MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW 16MM THREAD 50MM; SCREW, FIXATION, BONE

Model Number	208.405
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year is reported as 2021; however exact date of postoperative screw breakage is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 in (b)(6) 2020, tubercle osteotomy was performed with a 6.5 partially threaded cannulated screw and a 4.5 partially threaded cannulated screw.On an unknown date in (b)(6) 2021 the patient came back into office and it was identified that both screws are broken.There are no plans as of now to bring patient back for procedure.No further information provided.This report is for (1) 6.5mm cannulated screw 16mm thread 50mm.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 6.5MM CANNULATED SCREW 16MM THREAD 50MM
• 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: 12617341
• Report Number: 2939274-2021-06002
• Device Sequence Number: 16500906
• Product Code: HWC
• UDI-Device Identifier: 10886982149121
• UDI-Public: (01)10886982149121
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/14/2021

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: 208.405
• Device Catalogue Number: 208.405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention