MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM; SCREW, FIXATION, BONE

Model Number	02.211.022
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hrs.Reporter is a j&j sales representative.A product investigation was completed: upon visual inspection it was noticed that the external threads of the screw were stripped.No other defects were identified on the device.No dimensional inspection was done due to confirmed post manufacturing damage.The current and manufactured to drawing was reviewed.The complaint condition was confirmed as the external threads of the screw were noticed stripped.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 (b)(6) 2020, the patient underwent a revision procedure due to a broken variable angle-locking compression (va-lcp) distal humeral plate.Initially, the patient was implanted with the reported device three (3) weeks ago.During the revision procedure, the broken plate was removed, and the patient was revised to another plate.It is unknown if there was a surgical delay.Patient status, and surgical outcome were unknown.Concomitant device reported: screws (part unknown, lot unknown, quantity 5), va locking screw (part 02.211.050, lot unknown, quantity 1), va locking screw (part 02.211.018, lot unknown, quantity 1), va locking screw (part 02.211.020, lot unknown, quantity 1), va locking screw (part 02.211.028, lot unknown, quantity 1).During the investigation by the manufacturer, it was noted the locking screw was stripped.This report is for a locking screw.This is report 2 of 2 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM
• 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: 11011762
• Report Number: 2939274-2020-05577
• Device Sequence Number: 19731611
• Product Code: HWC
• UDI-Device Identifier: 10886982053626
• UDI-Public: (01)10886982053626
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• 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): 10/22/2020

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: 02.211.022
• Device Catalogue Number: 02.211.022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1