MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CHISEL GUIDE WITH ADJUSTABLE ANGLE; GUIDE, SURGICAL, INSTRUMENT

Model Number	332.09
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
Product complaint # (b)(4).Additional narrative: without a valid lot number the device history records review could not be completed.Complainant device is not expected to be returned for manufacturer review/investigation.Initial reporter is j&j company representative.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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, during an unknown procedure, two depth gauge tip was bent and broke.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 an unknown allegation.There was a surgical delay of five minutes.Procedure outcome is unknown.No patient consequence.This complaint involves twenty-three (23) devices.This report is for four (4) of the 23 devices.This report is for one (1) chisel guide with adjustable angle.This report is 4 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5 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 2 of 6 for (b)(4).

• Brand Name: CHISEL GUIDE WITH ADJUSTABLE ANGLE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12036397
• Report Number: 2939274-2021-03093
• Device Sequence Number: 14892953
• Product Code: FZX
• UDI-Device Identifier: 10886982192523
• UDI-Public: (01)10886982192523
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• 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: 332.09
• Device Catalogue Number: 332.09
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP; 2.0 THRDD GUIDE F/ 2.7 SCR VA AND LCP