MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE ACORNREAM 10MM THIN *EA; CANNULATED SURGICAL DRILL

Catalog Number	219335
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the complaint device was received and evaluated.Visual observation reveals the device appears worn.The distal tip of the reamer appears worn and dull.This complaint can be confirmed.There was no lot number etched on the complaint device, this indicates it is over 4 years old, as mitek began etching lot numbers on this product in october 2015.The likely root cause for this complaint is fair wear and tear due to age and use.The potential cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via email that during an acl procedure it was found that their acorn reamer 10 mm is dull.The procedure was completed with another like device with no patient harm or surgical delay to the case.The sales rep could not provide a lot number for the device.The device will be returning for evaluation.

• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9598424
• Report Number: 1221934-2020-00234
• Device Sequence Number: 14353543
• Product Code: HTO
• UDI-Device Identifier: 10886705005802
• UDI-Public: 10886705005802
• Combination Product (Y/N): N
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/15/2020

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: 219335
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1