MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE; GUIDE, SURGICAL, INSTRUMENT

Model Number 03.010.044

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j 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 Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2022, the connecting screws for the insertion handles were cross threaded and very difficult to unscrew of the implant.There was no surgical delay and no patient consequence reported.This report is for one (1) cannulated connecting screw for standard insertion handle this is report 2 of 2 for complaint (b)(4).

• Brand Name: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
• Type of Device: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13802409
• MDR Text Key: 291820690
• Report Number: 2939274-2022-00916
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982067166
• UDI-Public: (01)10886982067166
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.044
• Device Catalogue Number: 03.010.044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK-IMPLANT