MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 TI LCP OLECRANON PL 6 HOLES/RT/138; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	436.506
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 the usa as follows: it was reported that on (b)(6) 2022, patient underwent a revision surgery due to non-union and broken hardware.Patient presented with non-union in presence of a broken olecranon plate.Broken plate was implanted ¿over a year ago¿ as per surgeon.Surgeon performed revision surgery to remove broken plate, implant vivigen bone graft, and re-plate using a synthes variable angle olecranon plate.Procedure was completed successfully.It is unknown if there was surgical delay.Patient outcome was unknown.Concomitant device reported: unk - bone graft harvesting (part# unknown, lot# unknown, quantity# unknown); unk - screws: locking (part# unknown; lot# unknown; quantity: unknown).This complaint involves one(1) device 3.5 ti lcp olecranon pl 6 holes/rt/138.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5 TI LCP OLECRANON PL 6 HOLES/RT/138
• 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
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron 3942 ; SZ 3942
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14135988
• Report Number: 2939274-2022-01338
• Device Sequence Number: 20396594
• Product Code: KTT
• UDI-Device Identifier: 10886982217974
• UDI-Public: 10886982217974
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K000684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 436.506
• Device Catalogue Number: 436.506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - BONE GRAFT HARVESTING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown