MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	212.105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); No Code Available (3191)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event year is known.Additional device product codes: jds.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.(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) 2017, the patient underwent open reduction internal fixation with plates and screws and compression due to nonunion left proximal ulna s/p orif monteggia fracture subluxation.On (b)(6) 2017, the patient underwent an open reduction and internal fixation of the comminuted left proximal ulna and where a synthes device was implanted.Prior to the reported event, the patient tripped over a curb and fell her on her left upper extremity resulting to an immediate severe pain.Concomitant devices reported: 2.0mm cortex screw slf-tpng with stardrive recess 24mm (part number 201.374.97, lot unknown, quantity 1), 2.7mm/3.5mm va-lcp olecranon pl 4h/lt/116mm (part number 02.107.304, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/28mm (part number 02.118.528, lot unknown, quantity 1), 2.7mm metaphyseal scr slf-tpng w/t8 strdrv recess/34mm (part number 02.118.534, lot unknown, quantity 1), 2.7mm va lckng screw slf-tpng with t8 stardrive recess 20mm (part number 02.211.020, lot unknown, quantity 2), 2.7mm va lckng screw slf-tpng with t8 stardrive recess 22mm (part number 02.211.022, lot unknown, quantity 1).This report involves one (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 18mm.This is report 2 of 8 for (b)(4).This product complaint, (b)(4), captures eight (8) out of eighteen (18) devices of the second revision.(b)(4) captures ten (10) out of eighteen (18) devices.(b)(4) captures the third revision ten (10) out of fifteen (15) devices and (b)(4) captures the remaining five (5) out of fifteen (15) devices.(b)(4) captures the first revision, removal of radial head and stem that involves two (2) devices.

• Brand Name: 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10444157
• Report Number: 2939274-2020-03752
• Device Sequence Number: 2452430
• Product Code: KTT
• UDI-Device Identifier: 10886982151797
• UDI-Public: (01)10886982151797
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 212.105
• Device Catalogue Number: 212.105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 137