MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM; DRILL, BONE, POWERED

Model Number	317.82
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that while drilling the hole with a 1.5mm drill bit using the 12mm stop, the drill bit fractured and remained within the hole between the jaw bone and the prosthesis to be implanted.The drill fragment was removed.This report is for one (1) 1.5mm drill bit/mini qc with 12mm stop/44.5mm.This is report 1 of 1 for (b)(4).

• Brand Name: 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11195860
• Report Number: 2939274-2021-00374
• Device Sequence Number: 17113238
• Product Code: DZI
• UDI-Device Identifier: 10887587038773
• UDI-Public: 10887587038773
• 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
• Report Date (Section B): 12/22/2020

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
• Operator of Device: Health Professional
• Device Model Number: 317.82
• Device Catalogue Number: 317.820
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention