MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.75MM HEALIX KNOTLESS BR; SOFT-TISSUE ANCHOR, BIODEGRADABLE

Catalog Number	222286
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2013
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.Evaluation statement: the complaint device was received and evaluated.Visual observation of the device reveals the distal tip of the anchor was slightly bent and the anchor was off the inserter.From a follow up report it was noted that the surgeon prepared the bone holes correctly and there does not seem to be a definitive root cause for this failure.Although the failure can be confirmed, we cannot discern a root cause for this issue.A batch review was conducted and the results indicate that this batch was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints from this lot of devices released to distribution.At this point in time, 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.This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
Affiliate reported that first anker damaged sutters from the first row (orthocord); second anker didn't hold in the bone.Please see also medwatch report 1221934-2018-52065.

• Brand Name: 4.75MM HEALIX KNOTLESS BR
• Common Device Name: SOFT-TISSUE ANCHOR, BIODEGRADABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7693543
• Report Number: 1221934-2018-52070
• Device Sequence Number: 16582837
• Product Code: MAI
• UDI-Device Identifier: 10886705020386
• UDI-Public: 10886705020386
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K112249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2013

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: 02/29/2016
• Device Catalogue Number: 222286
• Device Lot Number: 3680971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2013
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1