MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number 04.005.530

Device Problem Material Twisted/Bent (2981)

Patient Problems Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The locking screw (product code: 04.005.530 , lot number: unknown) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the threads were stripped.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was done due to post manufacturing defect.Document review: 5.0mm locking screw.Complaint confirmed? yes, the device received was stripped.Hence confirming the allegation.Investigation conclusion: the complaint condition of stripped was confirmed for the locking screw (product code: 04.005.530 , lot number: unknown).Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.(b)(4).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 (b)(6) 2020, the patient underwent femur revision due to non-union and broken proximal femoral nailing system (tfna) long nail.The patient's status was good and a new proximal femoral nailing system (tfna) was implanted.Fragments were generated from the broken device and were easily removed.Procedure was successfully completed.This report is for one (1) 5.0mm ti locking screw w/t25 stardrive 40mm for im nails.This is report 3 of 3 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS
• Type of Device: SCREW, FIXATION, BONE
• 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: 10420151
• MDR Text Key: 203351300
• Report Number: 2939274-2020-03593
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982085986
• UDI-Public: 10886982085986
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000089
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.005.530
• Device Catalogue Number: 04.005.530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50