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

Catalog Number	219340
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received for evaluation.Visual inspection under magnification reveals that there are several nicks and cuts on the flutes of the reamer.Also, the cutting surfaces on the device are dull and not sharp.This complaint can be confirmed.No lot number was supplied which precludes conducting a manufacturing record evaluation.The probable root causes of this failure are repeated usage of the device drilling into a hard surface and during the sterilization process the devices are placed in a tray and they hit against each other and could cause the nicks that were observed.No further information regarding the cause of the defect has been provided to help determine the actual root cause for this failure.At this point in time, no corrective action is required, and no further action is warranted.However, 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 phone that during an acl procedure the surgeon found that the sales rep's restore full flute reamer 7mm, restore full flute reamer 7.5mm, restore full flute reamer 8mm, restore full flute reamer 8.5mm, restore full flute reamer 9mm, restore full flute reamer 9.5mm, and restore full flute reamer 10mm are all dull.The procedure was able to be completed with the devices with no patient harm or surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information or lot numbers for the devices.The devices 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: 9433474
• Report Number: 1221934-2019-59890
• Device Sequence Number: 19625319
• Product Code: HTO
• UDI-Device Identifier: 10886705005857
• UDI-Public: 10886705005857
• 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): 12/05/2019

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: 219340
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/06/2019
• Patient Sequence Number: 1