MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 1.8MM DRILL BIT/QC/100MM; DRILL, BONE, POWERED

Catalog Number 310.510

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involvement was reported.Device is an instrument and is not implanted/explanted.Returned to manufacturer customer quality conducted an investigation of the returned device.Cq investigation: visual inspection revealed a small nick/dent on the proximal coupling corner, but nothing that would inhibit functionality.Touching the distal drill bit tip and cutting flutes revealed dullness.It is possible that the reporter considered the 5 year old drill bit to be dull, but reported it as damaged.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.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.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.A dimensional inspection was not performed at cq because the dullness was confirmed by touch and the nick was visually confirmed.Dhr review: part number: 310.510.Synthes lot number: u160017, supplier lot number: u160017, release to warehouse date: 31-oct-2012.Supplier: (b)(4).Manufacturing site: (b)(4).No ncrs were generated during production.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 Description

It was reported that the 1.8mm drill bit was identified to be damaged before surgery.The drill bit appeared longer at the tip.Surgical staff did not feel comfortable using the device, it was discarded and not used for the procedure.There is no patient involvement or surgical delay reported.Investigation of the returned device revealed it is dull.This report is for one (1) 1.8mm drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 1.8MM DRILL BIT/QC/100MM
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7197477
• MDR Text Key: 97723218
• Report Number: 2939274-2018-50293
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10887587035154
• UDI-Public: (01)10887587035154(10)U160017
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/17/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 310.510
• Device Lot Number: U160017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1