MAUDE Adverse Event Report: DEPUY MITEK LOW PROFILE REAMER, 9.5MM; MITEK ACL INSTRUMENTS

Catalog Number	219631
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: 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
The sales rep reported via phone call that the customer's low profile reamer 9.5mm failed during an acl repair procedure due to the top portion of the reamer breaking off.The piece was removed from the patient and no debris left inside.There were no adverse patient consequences or time delay.The case was completed with another like device.The device will be returned for evaluation.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Additional Manufacturer Narrative
Additional narrative: the complaint device was received and evaluated.Visual examination revealed that the tip of the reamer was broken off at the distal end of the shaft where the flute begins, confirming this complaint.The broken fragment was not returned.This failure can be attributed to the use of excess force during device use, which is a user technique issue.Additionally, visual examination revealed some corrosion around the laser markings.The sales rep indicated that this device was used at several different facilities and no information regarding their autoclave and cleaning parameters is available.Therefore, a root cause for the observed corrosion and the time at which this issue occurred cannot be determined.Review of the device history record indicated that this batch of product was processed without incident; therefore, there is no internally assignable cause for the reported issue.Review of the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.(b)(4).
Event or Problem Description
The sales rep reported via phone call that the customer's low profile reamer 9.5mm failed during an acl repair procedure due to the top portion of the reamer breaking off.The piece was removed from the patient and no debris left inside.There were no adverse patient consequences or time delay.The case was completed with another like device.The device will be returned for evaluation.

• Brand Name: LOW PROFILE REAMER, 9.5MM
• Common Device Name: MITEK ACL INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6268989
• Report Number: 1221934-2017-10033
• Device Sequence Number: 16163731
• Product Code: HTO
• UDI-Device Identifier: 10886705024407
• UDI-Public: (01)10886705024407(10)1609001
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2017
• Report Date (Section F): 01/05/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 219631
• Device Lot Number: 1609001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/21/2017
• Supplement Report FDA Received Date: 02/21/2017; 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1