MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM; PLATE, FIXATION, BONE

Model Number	201.370.97
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.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 6mm (part number 201.356.97, lot unknown, quantity 1), 2.0mm cortex screw slf-tpng with stardrive recess 12mm (part number 201.362.97, lot unknown, quantity 1), 2.0mm cortex screw slf-tpng with stardrive recess 16mm (part number 201.366.97, lot unknown, quantity 1), 2.0mm cortex screw slf-tpng with stardrive recess 18mm (part number 201.368.97, lot unknown, quantity 1), 2.0mm lcp(tm) plate 4 holes/31mm (part number 247.344, lot unknown, quantity 1), 3.5mm cortex screw self-tapping 16mm (part number 204.816, lot unknown, quantity 1), 3.5mm cortex screw self-tapping 20mm (part number 204.82, lot unknown, quantity 2), 2.0mm cortex screw slf-tpng with stardrive recess 24mm (part number 201.374.97, lot unknown, quantity 1).This report involves one (1) 2.0mm cortex screw slf-tpng with stardrive recess 20mm.This is report 5 of 10 for (b)(4).This product complaint, (b)(4), captures the second revision, open reduction internal fixation with plates and screws and compression, that involves ten (10) out of eighteen (18) devices.(b)(4) captures the remaining eight (8) out of eighteen (18) devices.(b)(4) captures the third revision that involves ten (10) out of fifteen (15) devices.(b)(4) captures the remaining five (5) out of fifteen (15) devices.(b)(4) captures the first revision, the removal of radial head and stem, and involves two (2) devices.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.

• Brand Name: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM
• 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: 10442606
• Report Number: 2939274-2020-03745
• Device Sequence Number: 3974922
• Product Code: HRS
• UDI-Device Identifier: 10886982141934
• UDI-Public: (01)10886982141934
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• 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,Followup
• 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: 201.370.97
• Device Catalogue Number: 201.370.97
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0MM CORTEX SCREW 18MM; 2.0MM CORTEX SCREW SLF-TPNG 12MM; 2.0MM CORTEX SCREW SLF-TPNG 16MM; 2.0MM CORTEX SCREW SLF-TPNG 24MM; 2.0MM CORTEX SCREW SLF-TPNG 6MM; 2.0MM LCP(TM) PLATE 4 HOLES/31MM; 3.5MM CORTEX SCREW SELF-TAPPING 16MM; 3.5MM CORTEX SCREW SELF-TAPPING 20MM; 3.5MM CORTEX SCREW SELF-TAPPING 20MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Weight: 137