MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL; SCREW,FIXATION,BONE

Model Number	03.231.005
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, the unknown variable angle condylar aiming arm, the threaded guide that locked the aiming arm into the plate were stripped.Thought about this after the fact.It's two (2) of them and the thread is stripped so didn't engage the plate.There was no surgery date and no patient to identify with.There was no patient were identified because it did not find to solve the case.There was no known hospital or patient involvement.Concomitant device reported: unk - guides/sleeves/aiming: aiming arm (part# unknown; lot# unknown; quantity: unknown); unk - plates: 4.5mm va lcp condylar plate (part# unknown; lot# unknown; quantity: unknown).This complaint involves two (2) devices.This report is for (1) interlckng bolt 4.5 va cond insertn hndl.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint (b)(4).Additional product code: jdp, hrs.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.

• Brand Name: INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13214786
• Report Number: 2939274-2022-00103
• Device Sequence Number: 17498197
• Product Code: HWC
• UDI-Device Identifier: 10886982077325
• UDI-Public: (01)10886982077325
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K110354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.231.005
• Device Catalogue Number: 03.231.005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 01/10/2022
• 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: INTERLCKNG BOLT 4.5 VA COND INSERTN HNDL; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - PLATES: 4.5MM VA LCP CONDYLAR PLATE
• Patient Sex: Unknown