MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM DRILL BIT/QC/145MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.31
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: patient¿s identifier is unknown.(b)(4).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.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 a patient underwent an open reduction internal fixation (orif) surgery of the right distal femur on (b)(6) 2017 to treat a fracture.While the surgeon was drilling with a 3.2mm drill bit, the tip of the drill broke off.The fragment was retrieved.A back-up drill bit was available for surgeon to successfully complete the procedure.There was no reported delay.No harm was reported to the patient.Patient outcome was reported stable.Concomitant devices reported: drill (part # unknown, lot # unknown, quantity:1).This report is for one (1) 3.2mm drill bit/qc/145mm.(b)(4).
Additional Manufacturer Narrative
The device was received and the product evaluation is in progress.No conclusion can be drawn.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.
Additional Manufacturer Narrative
Additional narrative: dhr review was completed.Part number: 310.31.Synthes lot number: u263619.Supplier lot number: n/a.Release to warehouse date: 15-mar-2017, 20-mar-2017, 24-mar-2017.Expiration date: n/a.Supplier: orchid unique.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.Customer quality conducted an investigation of the returned device.The returned 3.2mm drill bit with quick coupling 145mm length is an instrument available for use in several systems to drill the core diameter pathway for 4.0mm locking screws and 4.5mm cortex screws.This complaint is confirmed.A portion of the distal tip of the returned drill bit has sheared off mid-flute and was not returned.Additionally, the remaining distal fluted tip deformed/twisted and bent prior to ultimately breaking.The deformation pattern suggests that the drill bit tip contacted another metallic device under power which led to the device ultimately breaking.The remaining drill bit length measured 135mm, therefore the distal fragment that sheared off would be approximately 10.0-12.0mm in length with reference to drawing overall length specification of 147.0mm +0.3/-2.0mm.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken.No new malfunctions were identified as a result of the investigation.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.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The diameter of the returned drill bit near location of breakage measured 3.188mm at cq which is within specification of 3.2mm -0.03mm per drawing.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 3.2MM DRILL BIT/QC/145MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7183657
• Report Number: 2939274-2018-50166
• Device Sequence Number: 13710356
• Product Code: HWE
• UDI-Device Identifier: 10886982186478
• UDI-Public: (01)10886982186478(10)U263619
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/14/2017

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 Catalogue Number: 310.31
• Device Lot Number: U263619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 01/12/2018; 02/08/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 01/17/2018; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 64