MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP PLUS ANCHOR W/PAN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210707
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.A non-conformance search was performed for this product code 210707-lot #3738136 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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 etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the affiliate in (b)(6) that during a shoulder instability surgical procedure, it was observed that the suture broke while tensioning.According to the reporter, the thread was ripped in the knot while the anchor was still implanted in the patient.It was further reported that the anchor broke but it has been removed completely and nothing was left in the patient.It was reported that it might have due to the surgeon being off-axis.It was reported that the original bone hole was used to complete the procedure.There was a delay of not more than five minutes.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: LUPINE LOOP PLUS ANCHOR W/PAN
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8253856
• Report Number: 1221934-2018-51340
• Device Sequence Number: 2125316
• Product Code: MAI
• UDI-Device Identifier: 10886705001057
• UDI-Public: 10886705001057
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2016

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: 210707
• Device Lot Number: 3738136
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2016
• Initial Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1