MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/70MM; SCREW, FIXATION, BONE

Model Number	02.127.170
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code:: hrs.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in usa as follows: it was reported that on an unknown date, during an open reduction internal fixation (orif) of the proximal tibia for the deformity correction, a 70mm variable angle (va) locking screw went through the proximal posterior locking hole.It sunk into the hole slightly past the threaded holes, but the screw was retained.A new locking screw 70mm was used without any issues.There was a surgical delay of one (1) minute, and the procedure was completed successfully.There was no patient consequence.Concomitant devices: 3.5mm va-lcp proximal tibial plate (part # 02.127.320, lot # 3l92975, quantity 1).Unknown locking screw (part # unknown, lot # unknown, quantity 5).This report is for 1 3.5mm variable angle locking screw.This is report 1 of 1 for (b)(4).

• Brand Name: 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/70MM
• 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: 9371503
• Report Number: 2939274-2019-62379
• Device Sequence Number: 19567296
• Product Code: HWC
• UDI-Device Identifier: 10886982043368
• UDI-Public: (01)10886982043368
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/08/2019

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: 02.127.170
• Device Catalogue Number: 02.127.170
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/25/2019
• Patient Sequence Number: 1