MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBIALSHEATH 30MM *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
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) - incomplete.The expiration date is not currently available.Associated medwatch: 1221934-2018-50704, 1221934-2018-50703, and 1221934-2018-50706.
Event or Problem Description
It was reported via phone by the sales rep that during an acl procedure, the doctor inserted the intrafix tibial sheath fine, but when he was trying to insert the intrafix peek screw, it would not screw in the bone.The doctor stated the sheath was getting damaged due to the patient's hard bone, and removed the sheath.The doctor attempted to insert another sheath and screw, but the same thing happened.The doctor then re-dilated the hole and using the same size sheath and screw successfully completed the procedure.There were no patient consequences or delays.No replacement devices were sent out, just a trunk adjustment.
Event or Problem Description
It was reported via phone by the sales rep that during an acl procedure, the doctor inserted the intrafix tibial sheath fine, but when he was trying to insert the intrafix peek screw, it would not screw in the bone.The doctor stated the sheath was getting damaged due to the patient's hard bone, and removed the sheath.The doctor attempted to insert another sheath and screw, but the same thing happened.The doctor then re-dilated the hole and using the same size sheath and screw successfully completed the procedure.There were no patient consequences or delays.No replacement devices were sent out, just a trunk adjustment.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device is not being returned, therefore is unavailable for a physical evaluation.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Therefore, we cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode.A review into the mitek complaints system revealed no other complaint of any kind for this lot of devices.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.Udi: (b)(4).Associated medwatch: 1221934-2018-50704, 1221934-2018-50703 and 1221934-2018-50706.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7530151
• Report Number: 1221934-2018-50705
• Device Sequence Number: 1512051
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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 Expiration Date: 10/31/2020
• Device Catalogue Number: 254601
• Device Lot Number: L630410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1