MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM CANNULATED DRILL BIT LARGE QC/300MM; BIT,DRILL

Model Number	310.63
Medical Device Problem Codes	Entrapment of Device (1212); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 during an elbow fracture procedure on (b)(6) 2020, the tip of the 5.0 drill bit was broken.The issue occurred while drilling the cortex with the 6.5 and 7.3mm cannulated screw at the washer.The broken piece of the drill bit was not able to be retrieved.The procedure was successfully completed by proceeding with screw placement.It is unknown if there was a surgical delay.Patient status is unknown.Concomitant device reported: unknown 6.5mm/7.3mm cannulated screw (part # unknown, lot # unknown, quantity unknown), unknown washer (part # unknown, lot # unknown, quantity unknown), unknown 2.8mm k wire (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.This report is for (1) 5.0mm cannulated drill bit large qc/300mm.This report is 1 of 1 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.H6: a device history record (dhr) review was conducted: part number:310.63.Synthes lot number: pe04204.Supplier lot number: n/a.Release to warehouse date: 25feb2020.Expiration date: n/a.Supplier: precision edge surgical products.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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: 5.0MM CANNULATED DRILL BIT LARGE QC/300MM
• 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: 11139488
• Report Number: 2939274-2021-00084
• Device Sequence Number: 4043035
• Product Code: HTW
• UDI-Device Identifier: 10886982186812
• UDI-Public: (01)10886982186812
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 310.63
• Device Catalogue Number: 310.63
• Device Lot Number: PE04204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - GUIDE/COMPRESSION/K-WIRES.; UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED.; UNK - WASHERS.; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - SCREWS: 6.5 MM AND 7.3 MM CANNULATED; UNK - WASHERS
• Outcome Attributed to Adverse Event: Required Intervention