MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; PLATE,FIXATION,BONE

Model Number	02.211.012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: hwc.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 on october 1, 2020 that the patient underwent revision surgery due to nonunion of one (1) variable angle (va) locking compression plate (lcp) extended medial distal humerus plate, seven (7) va locking screw, one (1) cortex screw and one (1) va lcp distal humerus plate.Patient outcome was unknown.There was no surgical delay.The procedure was successfully completed.Fragments were generated and easily removed.This report is for one (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 12mm.This is report 2 of 10 for (b)(4).
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.
Event or Problem Description
Updated event description: it was reported on (b)(6) 2020, that patient underwent revision surgery due to nonunion and 1 broken 60mm length va locking screw.One (1) variable angle (va) locking compression plate (lcp) extended medial distal humerus plate, seven (7) va locking screws and one (1) cortex screw and one (1) va lcp distal humerus plate were successfully explanted.There was a fragment of the shaft and the screwhead but it was removed easily without added time.Patient outcome was unknown.This complaint involves ten (10) devices.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM
• 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: 10752295
• Report Number: 2939274-2020-04863
• Device Sequence Number: 14396145
• Product Code: HRS
• UDI-Device Identifier: 10886982053565
• UDI-Public: (01)10886982053565
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 02.211.012
• Device Catalogue Number: 02.211.012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention