MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6 COMP WIRE 15 THREAD/150 LENGTH; INSTRUMENT, COMPRESSION

Model Number	03.211.415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, while trying to remove the temporary compression wire from the clavicle plate in the bone, the compression wire broke at the junction of the ball and the wire.The compression wire ball and threaded tip end was still remaining and held down the plate to the bone.The surgeon had to use multiple instruments to remove the remaining compression wire ball and threaded tip from the plate.The remaining compression wire ball and threaded tip were successfully removed.Removing compression wire with a wire driver needed to use multiple instruments to grasp the remaining compression wire ball.Procedure was completed successfully with twenty (20) minutes surgical delay.Concomitant device reported: unk - cable/wire instruments (part# unknown; lot# unknown; quantity: unknown).Unk - plates: lcp clavicle plate (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) 1.6 comp wire 15 thread/150 length.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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: 1.6 COMP WIRE 15 THREAD/150 LENGTH
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12923987
• Report Number: 2939274-2021-06950
• Device Sequence Number: 5647687
• Product Code: HWN
• UDI-Device Identifier: 10886982076304
• UDI-Public: (01)10886982076304
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 03.211.415
• Device Catalogue Number: 03.211.415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE INSTRUMENTS; UNK - PLATES: LCP CLAVICLE PLATE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown