MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	EL-2520S4
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes 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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during an unknown procedure, the drill bit became bent and broke.No further information was provided.This report is for one (1) 1.1mm drill bit/mini qc with 12mm stop/44.5mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
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: d2: additional procodes: hwe, dzi, hbe d7, d10.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
The event occurred on (b)(6) 2021, and additional drill bits were used to complete the procedure without complications.The damage of the drill bits did not produce consequences.
Additional Manufacturer Narrative
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.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: 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11938057
• Report Number: 2939274-2021-02763
• Device Sequence Number: 4250541
• Product Code: ERL
• UDI-Device Identifier: 00810633021705
• UDI-Public: (01)00810633021705
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2021

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: EL-2520S4
• Device Catalogue Number: 317.320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 09/17/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/02/2021; 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø1.1 W/STOP L44.5/8.; DRILL BIT Ø1.1 W/STOP L44.5/8.; DRILL BIT Ø1.1 W/STOP L44.5/8.