MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM-STERILE; BIT, DRILL

Catalog Number	03.010.104S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).Medwatch#: mw5076783.
Event or Problem Description
This report is against user facility medwatch number mw5076783, a copy is attached.The only information contained in this report is correction or additional information.It was reported that during an unknown procedure on (b)(6) 2018, a drill bit broke inside the femoral neck while drilling.The drill bit was not removed.Patient and surgical outcomes are unknown.A surgical delay is unknown.This report is for a 4.2mm three-fluted drill bit qc/needle point/145mm-sterile.This is report 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.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
Part 03.010.104s, lot 7721917: release to warehouse date: (b)(6) 2014.No non-conformance 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.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
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.Part 03.010.104s, lot 7721917: release to warehouse date: july 08, 2014.No non-conformance 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.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: 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM-STERILE
• 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: 7553356
• Report Number: 2939274-2018-52337
• Device Sequence Number: 1187236
• Product Code: HTW
• UDI-Device Identifier: 10886982067753
• UDI-Public: (01)10886982067753
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 03.010.104S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 05/21/2018; 06/28/2018; 07/06/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/11/2018; 07/02/2018; 07/06/2018
• 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