MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 44MM; APPLIANCE,FIXATION,NAIL

Model Number	212.134
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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.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 an unknown date, during open reduction internal fixation (orif) lt distal tibia fracture the surgeon remarked 3.5 locking screw 42mm and 3.5 locking screw 44mm would not lock into medial distal tibia plate.The surgeon left all three implants in the patient.There was a surgical delay of ten minutes.The patient outcome was good.This complaint involves three (3) devices.This report is for (1) 3.5mm locking screw slf-tpng with stardrive recess 44mm.This is report 3 of 3 for (b)(4).

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 44MM
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10627658
• Report Number: 2939274-2020-04487
• Device Sequence Number: 2901366
• Product Code: KTT
• UDI-Device Identifier: 10886982152060
• UDI-Public: (01)10886982152060
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000684
• 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): 09/12/2020

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: 212.134
• Device Catalogue Number: 212.134
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2020
• Initial Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1
• Patient Age: 51 YR