MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN CHISEL FOR ADULT ANGD BLADE PLS 320; CHISEL, SURGICAL, MANUAL

Model Number	332.121
Medical Device Problem Codes	Corroded (1131); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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.
Event or Problem Description
It was reported that on an unknown date, the patient underwent an unknown surgery.During the procedure, two depth gauge tips were bent and broken.Eight threaded drill guide, four drill bit, two end cap, two cannulated chisel, two chisel guide, and locking compression plate (lcp) proximal humerus plate had were involved in threads stripping va locking holes.Chisel and guide were bent during process of insertion.No fragments were generated.There was a surgical delay of five minutes.Procedure outcome is unknown.No patient consequence.This report is for (1) cann chisel for adult angd blade pls 320.This report is 6 of 6 for (b)(4).

• Brand Name: CANN CHISEL FOR ADULT ANGD BLADE PLS 320
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12091752
• Report Number: 2939274-2021-03327
• Device Sequence Number: 4166727
• Product Code: FZO
• UDI-Device Identifier: 10886982192561
• UDI-Public: (01)10886982192561
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 332.121
• Device Catalogue Number: 332.121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1