MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM IMF SCREW SELF-DRILLING 8MM; SCREW FIXATION INTRAOSSEOUS

Model Number 201.928

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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, in the past 4 (four) weeks, the surgeon had (ten) 10 different items screws including the screw self-drilling 8mm broke.It is unknown how many screws were broken.Fragments were generated from broken devices had to drill out.There was a surgical delay of ten (10) minutes.Procedure was successfully completed just had to put in another screw.Patient outcome had to leave some of the broken screw inside the tissue.This complaint involves two (2) devices.This report is 1 of 2 for (b)(4).

• Brand Name: 2.0MM IMF SCREW SELF-DRILLING 8MM
• Type of Device: SCREW FIXATION INTRAOSSEOUS
• 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: 8697988
• MDR Text Key: 148005570
• Report Number: 2939274-2019-58646
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 20887587028634
• UDI-Public: (01)20887587028634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201.928
• Device Catalogue Number: 201.928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention