MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM; BIT, DRILL

Model Number	03.130.201
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on (b)(6) 2020, patient underwent an orthopedic procedure, surgeon was plating the third mc hand fracture and broke the heads off of three (3) 1.5mm variable angle locking screws, and one (1) 1.5mm cortex screw.The heads were retrieved but the screw shafts remained in the patient.The surgeon also broke the tip off two (2) 1.1mm drill bits.One (1) was retrieved and a 4mm length piece of the other was left in the patient.The surgeon determined a stable fixation with the screws that were not broken.A circlage wire was placed around the plate both proximally and distally.Fragments generated from the broken screw shafts and a 4mm segment of the drill bit were left in the patient.There was a surgical delay of ten (10) minutes.Procedure was successfully completed.Patient outcome is unknown.Concomitant devices reported: 1.5mm va-lck scr slf-tp w t4 stardrive13mm, 1.5mm va-lck scr slf-tp w t4 stardrive12mm, 1.5mm va-lck scr slf-tp w t4 stardrive11mm, 1.5mm crtx scrw slf-tp w t4 stardr rec 11mm, 1.1mm dr bit/stryk j-latch f hl/65mm.This report is for one (1) 1.1mm drill bit/stryker j-latch f/threaded hole/65mm.This is report 2 of 2 for (b)(4).

• Brand Name: 1.1MM DRILL BIT/STRYKER J-LATCH F/THREADED HOLE/65MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10456810
• Report Number: 2939274-2020-03808
• Device Sequence Number: 14476272
• Product Code: HTW
• UDI-Device Identifier: 10886982075321
• UDI-Public: (01)10886982075321
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.130.201
• Device Catalogue Number: 03.130.201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 68