MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM DRILL BIT/QC/110MM; INSTR, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient weight is unknown.Additional procodes: hsz, gff, gfa.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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 on (b)(6) 2018, the patient underwent an elbow surgery.During the procedure, the two (2) drill bits broke while the surgeon was drilling.The fragments were retrieved and not retained in the patient.The procedure was completed successfully, with no reported delay.Patient status is good.This report is for a 1.5mm drill bit/qc/110mm.This is report 1 of 2 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.H10 additional narrative: a5: patient ethnicity is unknown.H3, h4, h6: dhr review: part: 310.16; synthes lot: u299476; supplier lot: u299476; release to warehouse date: january 05, 2018; supplier: orchid unique; manufacturing site: monument; no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 1.5MM DRILL BIT/QC/110MM
• 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: 7550174
• Report Number: 2939274-2018-52333
• Device Sequence Number: 13511133
• Product Code: HWE
• UDI-Device Identifier: 10886982186041
• UDI-Public: (01)10886982186041
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/08/2018

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: 310.16
• Device Lot Number: U299476
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR