MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/22MM; SCRE, FIXATION, BONE

Model Number	02.127.122
Medical Device Problem Code	Device Difficult to Maintain (3134)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional pro-code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 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 on (b)(6) 2019, the percutaneous drill bit broke during drilling and a back up devices was available.It was noted that the variable angle locking screw did not lock in the hole where the drill bit was left.There were fragments generated.The surgeon left the hole empty and moved to another hole.There was no surgical delay.The procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unknown drill (part # unknown, lot # unknown, quantity # 1).This complaint involves three (3) devices.This report is for one (1) 3.5mm variable angle locking screw/slf-tpng/strdrv/22mm.This report is 2 of 3 for (b)(4).

• Brand Name: 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/22MM
• Common Device Name: SCRE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8575732
• Report Number: 2939274-2019-57806
• Device Sequence Number: 1992633
• Product Code: HWC
• UDI-Device Identifier: 10886982043153
• UDI-Public: (01)10886982043153
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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: 02.127.122
• Device Catalogue Number: 02.127.122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 05/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR