MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM; PLATE,FIXATION,BONE

Model Number	02.130.212
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: hwc.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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, during open reduction internal fixation of the hand, the five (5) variable angle locking screws would not lock in the variable angle strut plate.The surgeon then had to remove the plate and choose a different plate to complete the surgery.The two (2) screws which the variable angle locking screws were tried in the same compromised hole of variable angle strut plate.While, the three (3) other screws were wasted after the surgeon requested new screws for the new plate.The surgeon felt the screw heads were compromised and did not want to damage the new plate.There was a surgical delay of ten (10) minutes.Procedure was successfully completed.Patient status and outcome were successful after an alternative plate was used.This complaint involves six (6) devices.This is report 6 of 6 for (b)(4).

• Brand Name: 1.5MM VA-LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 12MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9913244
• Report Number: 2939274-2020-01669
• Device Sequence Number: 16982866
• Product Code: HRS
• UDI-Device Identifier: 10886982044662
• UDI-Public: (01)10886982044662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 02.130.212
• Device Catalogue Number: 02.130.212
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention