MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM; SCREWDRIVERS

Model Number 03.503.071

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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.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 matrixm and ible thorax screwdriver blade self retaining medium was stripped and not retaining screws.Patient status is unknown.There is no patient consequence.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM
• Type of Device: SCREWDRIVERS
• 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
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10011399
• MDR Text Key: 191134126
• Report Number: 2939274-2020-02113
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10887587011875
• UDI-Public: (01)10887587011875
• Combination Product (y/n): N
• 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: 04/11/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.503.071
• Device Catalogue Number: 03.503.071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2020
• Initial Date FDA Received: 04/29/2020
• 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