MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM DRILL BIT/QC/165MM; BIT, DRILL

Model Number	310.288
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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
It was reported that on (b)(6) 2021, during a procedure the surgeon attempted to put a guide block and screw through the drill holes.The issue occurred while the attachment screw going to the patient's body via the guide block.We are doing a distal fibula plate for a patient and drilled for a locking screw then use the power shaft.The locking screw would not stick to the tip of the screwdriver shaft.Procedure was completed successfully with the hand screwdriver and a surgical delay of (30) seconds.Concomitant device reported: unk - screws: distal radius: (part#unknown; lot# unknown; quality:1).This report is for (1) 2.8mm drill bit/qc/165mm.This is report 2 of 6 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 2.8MM DRILL BIT/QC/165MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12665178
• Report Number: 2939274-2021-06181
• Device Sequence Number: 14572640
• Product Code: HTW
• UDI-Device Identifier: 10886982186423
• UDI-Public: (01)10886982186423
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 310.288
• Device Catalogue Number: 310.288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 11/15/2021
• 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: 2.8MM DRILL BIT/QC/165MM.; GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/RT.; LCP ONE-THIRD TUB PL COLLAR 10 H/117.; SDDRIVE SCREWDRIVER SHAFT QC/T15.; UNK - GUIDES/SLEEVES/AIMING: SLEEVE.; UNK - SCREWDRIVERS.; UNK - SCREWS: CORTEX.; UNK - TORQUE DEVICES.; 2.8MM DRILL BIT/QC/165MM; GUIDE BLOCK TWO-COLM PL/NARROW 6H HD/RT; LCP ONE-THIRD TUB PL COLLAR 10 H/117; SDDRIVE SCREWDRIVER SHAFT QC/T15; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - SCREWDRIVERS; UNK - SCREWS: CORTEX; UNK - TORQUE DEVICES
• Patient Sex: Unknown