MAUDE Adverse Event Report: DEPUY MITEK GII QUICK ANCHOR PLUS W/ #2 PANACRYL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212134
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.The complaint device was received and evaluated.Only the suture was sent back to mitek.Visual observation confirms the suture is cut.The suture is also slightly frayed.It is possible that one of the instruments used in the procedure had sharp edges that contributed to this failure.No additional procedural details were provided to confirm if the aforementioned cause contributed to the failure.Furthermore, no lot numbers were supplied, which precludes conducting a batch history review or a lot specific search in the complaints handling system.Other than the possibility mentioned above, we cannot discern a root cause for this failure at this time.At this point, no corrective action is required and 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.
Event or Problem Description
It was reported that the anchor was inserted into bone without complication; when surgeon pulled at the suture to check the fit of the anchor, the suture ruptured.The surgeon wanted to re-fixate with three anchors.Two anchors rupture at the suture, so he had to use five anchors to finish the procedure.There was a twenty (20) minute surgical delay.The surgeon stated that he did not pull excessively.The date of the procedure is unknown.

• Brand Name: GII QUICK ANCHOR PLUS W/ #2 PANACRYL
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8055356
• Report Number: 1221934-2018-52624
• Device Sequence Number: 1502245
• Product Code: JDR
• UDI-Device Identifier: 10886705001989
• UDI-Public: 10886705001989
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K915889
• 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): 09/25/2014

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: 212134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2014
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1