MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.540
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection: the 5.0mm ti locking screw w/t25 stardrive 50mm for im nails (p/n: 04.005.540, lot number: unk) was received at us customer quality (cq).Visual inspection of the complaint device showed the screw has damaged/deformed threads.Device failure/defect identified? yes.Dimensional inspection: specified dimensions: thread major diameter = max of 4.95mm.Measured dimensions: thread major diameter = 4.84mm, conforming.Device used - caliper ca215p.Document/specification review: current was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the screw threads are damaged.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 proximal femoral nailing system (tfna) nail broke.It is unknown if there was a patient involvement.Concomitant devices reported: tfna fenestrated helical blade 95mm - sterile (part# 04.038.395, lot# 36p4782, quantity# 1).This report is for one.This is report 2 of 2 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 50MM FOR IM NAILS
• 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: 11178351
• Report Number: 2939274-2021-00321
• Device Sequence Number: 14201806
• Product Code: HWC
• UDI-Device Identifier: 10886982086082
• UDI-Public: 10886982086082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2020

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: 04.005.540
• Device Catalogue Number: 04.005.540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/15/2021
• Patient Sequence Number: 1