MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL BIT Ø1.1 L70/39 F/CORE HOLE; BIT, DRILL

Catalog Number	03.130.200
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported that on (b)(6) 2022, dr.(b)(6) was performing an orif of the left 4th metacarpal.Using the synthes va locking hand system (1.5mm module).Dr.(b)(6) used the 1.1mm drill bit to perform a 1.5mm lag screw, but was unsuccessful.It was then determined that he would just plate and screw the fracture.After having continued difficulty with the 1.1 drill bit, dr.(b)(6) opted to switch to the 2.0mm module and the 1.5mm drill.During final films, it was discovered that the tip of the 1.1mm drill bit, used for the attempted lag screw, had broken off in the canal of the patients finger.Unnoticed by the doctor, or staff, or myself prior to final films.Dr.(b)(6) chose to leave the tip of the drill implanted as he felt the risk of losing reduction and the ability to fix the fracture outweighed leaving the sterile tip implanted.This complaints involves one (1) device drill bit ø1.1 l70/39 f/core hole.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DRILL BIT Ø1.1 L70/39 F/CORE HOLE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13938544
• Report Number: 2939274-2022-01105
• Device Sequence Number: 11960056
• Product Code: HTW
• UDI-Device Identifier: 07611819690585
• UDI-Public: (01)07611819690585
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 03.130.200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown