MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7 VA 1ST MTP FUSN PL/SM/5 DEG/LFT; SCREW, FIXATION, BONE

Model Number	02.211.233
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hrs.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 (b)(6) 2021, during the first metatarsophalangeal joint (mtp) fusion case one of the locking holes stripped and would not hold a locking screw, while putting the first screw in the plate.It was confirmed that screw is not the issue as it could locked into another hole.A backup plate was then used for the case.Procedure was completed successfully with five (5) minutes of surgical delay and no patient consequences.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity: 1).Unknown screwdriver (part# unknown, lot# unknown, quantity: 1).This report is for one (1) 2.4/2.7mm va-lcp first mtp fusion pl/sm/5 deg/left.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.4/2.7 VA 1ST MTP FUSN PL/SM/5 DEG/LFT
• 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: 11885632
• Report Number: 2939274-2021-02589
• Device Sequence Number: 19769978
• Product Code: HWC
• UDI-Device Identifier: 10886982054166
• UDI-Public: (01)10886982054166
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 02.211.233
• Device Catalogue Number: 02.211.233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 05/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention