MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC; BIT, DRILL

Catalog Number	03.010.228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed for part number: 03.010.228, synthes lot number: u151614, supplier lot number: n/a, release to warehouse date: 05-apr-2012, expiration date: n/a, supplier: (b)(4): no non-conformance reports (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.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 procedure for hip surgery on (b)(6) 2018, a drill bit for 5.0mm recon screws/large qc broke.The broken fragments of the drill bit were removed from the patient and an adolescent lateral entry femoral nail was used to complete the surgery.The procedure was completed with a surgical delay of almost 40 minutes and the patient was stable after the surgery.This report is for one (1) drill bit for 5.0mm recon screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC
• 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: 7245200
• Report Number: 2939274-2018-50526
• Device Sequence Number: 13710119
• Product Code: HTW
• UDI-Device Identifier: 10886982068101
• UDI-Public: (01)10886982068101(10)U151614
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 01/16/2018

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: 03.010.228
• Device Lot Number: U151614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 62