MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC; SCREWDIVERS

Model Number 03.130.010

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes rep.Without a lot number, the device history records review could not be completed as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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

It was reported that on an unknown date, the tip of the two (2) t4 screwdriver shafts were noticed slightly stripped upon routine inspection.There was no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC
• Type of Device: SCREWDIVERS
• 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: 9566934
• MDR Text Key: 190322297
• Report Number: 2939274-2020-00102
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982075192
• UDI-Public: (01)10886982075192
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.130.010
• Device Catalogue Number: 03.130.010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1