MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/20MM; SCREW, FIXATION, BONE

Model Number	02.127.120
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
Additional procode: hrs.Reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during an unknown procedure on an unknown date, a variable angle locking screw was stripped during insertion.The screw was removed and replaced with an intact screw.The surgeon was using the torque limiter on power when inserting the screw.The procedure was successfully completed.There was no patient consequence.This report is for a 3.5mm variable angle locking screw.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The 3.5 mm variable angle locking screw/slf-tpg/strdrv/20mm (p/n: 02.127.120, lot #: unk) was returned and received at us cq.Upon visual inspection, it was observed that the screw head internal threads that interact with the torque limiter for screw insertion were stripped.No other issues were observed with the returned device.The complaint condition was confirmed for the 3.5 mm variable angle locking screw/slf-tpg/strdrv/20mm (p/n: 02.127.120, lot #: unk).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 history lot = > p/n: 02.127.120, lot #: unk.Dhr was not performed due to unknown lot number.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.

• Brand Name: 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/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: 11294025
• Report Number: 2939274-2021-00718
• Device Sequence Number: 11692625
• Product Code: HWC
• UDI-Device Identifier: 10886982043146
• UDI-Public: (01)10886982043146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• 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,Followup
• Report Date (Section B): 01/20/2021

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: 02.127.120
• Device Catalogue Number: 02.127.120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - TORQUE DEVICES