MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.010.488
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Only event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the impact device broke off while attached to the insertion handle.The pieces could not be removed from the insertion handle.The screwdriver for synapse screws was cross threaded and would not properly thread into the screw heads.There was no patient consequence.This report involves one (1) radiolucent insertion handle for expert alfn/100mm.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Only event year is known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the impact device broke off while attached to the insertion handle.The pieces could not be removed from the insertion handle.The screwdriver for synapse screws was cross threaded and would not properly thread into the screw heads.There was no patient consequence.This report involves one (1) radiolucent insertion handle for expert alfn/100mm.This is report 1 of 3 for (b)(4).

• Brand Name: RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 13416467
• Report Number: 2939274-2022-00311
• Device Sequence Number: 20006126
• Product Code: HSB
• UDI-Device Identifier: 07611819498877
• UDI-Public: (01)07611819498877
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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 Catalogue Number: 03.010.488
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 02/01/2022
• 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: DRIVING CAP F/INSERTION HANDLE; UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown