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

Catalog Number	219340
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).The lot number is not currently available.Investigation summary: the complaint device was received and evaluated.Visual observation reveals the laser markings are slightly faded and the devices appear worn.From the appearance of the device, it can be determined that this device is old and possibly seen heavy use.This type of failure is typical of excessive abuse of the device and therefore can be attributed to user issue.Furthermore, as 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.However, depuy synthes 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.
Event or Problem Description
It was reported by the sales rep that during an anterior cruciate ligament (acl) surgical procedure, it was observed that the restore fullflute ream 10mm *ea was dull that it was very hard to create the holes in the bone.During in-house engineering evaluation, it was determined that the device was worn with heavy use that its laser markings were slightly faded.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Common Device Name: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9481421
• Report Number: 1221934-2019-60007
• Device Sequence Number: 11496485
• Product Code: HTO
• UDI-Device Identifier: 10886705005857
• UDI-Public: 10886705005857
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1