MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.3MM DRILL BIT/QC/180MM; BIT, DRILL

Catalog Number	310.431
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s identifier, date of birth/age and weight are unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation, as part was discarded by the facility.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 open reduction internal fixation (orif) of a distal femur on (b)(6) 2018, a drill bit broke and was left inside the patient.Surgeon was forcing the drill bit and broke it.The broken part was lost in the patient.The patient has a knee replacement, and that prevented the x-ray to reveal where the broken fragment was in the patient.The surgery was completed successfully with no delay.There weren't any negative results.This report is for one (1) 4.3mm drill bit/qc/180mm.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
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.(b)(4) - maude report mw5074982.
Event or Problem Description
This report is against user facility medwatch number mw5074982, a copy is attached.The only information contained in this report is correction or additional information.
Additional Manufacturer Narrative
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: 4.3MM DRILL BIT/QC/180MM
• 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: 7248912
• Report Number: 2939274-2018-50539
• Device Sequence Number: 16352358
• Product Code: HTW
• UDI-Device Identifier: 10886982186638
• UDI-Public: (01)10886982186638(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2018

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 Catalogue Number: 310.431
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/23/2018; 03/16/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 03/14/2018; 03/16/2018
• 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
• Patient Age: 79 YR