MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM; REAMER

Catalog Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 a trochanteric fixation nail surgery on (b)(6) 2018, a stepped cannulated drill bit was broken while drilling.There were tiny pieces of fragments removed from the patient but there were still some tiny pieces seen on x-ray.The procedure was completed successfully.Patient status is unknown.Concomitant device: drill: (part: unknown, lot: unknown, quantity: 1) this report is for a 6.0mm/10.0mm stepped drill bit cannulated/large qc/435mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM
• Common Device Name: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7874369
• Report Number: 2939274-2018-53762
• Device Sequence Number: 18880006
• Product Code: HTO
• UDI-Device Identifier: 10886982196262
• UDI-Public: (01)10886982196262
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 357.403
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/13/2018
• 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