MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS PLUS W/PANACRYL; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The batch review 3443260 showed that the devices were conformed to in process and finished goods specifications when released to stock the 10 aug.2010.Expiration date: 2013-07 (according to retained labels).Nc was opened relating to deals with the use of non accepted sutures in production (waiting for test results).Tests were conformed and sutures accepted after their use in production, with no link with this complaint.Nc was opened relating to deals with the use of a too high tensile strength to assemble sutures which broke during the assembly process.New parameters were validated for this suture, with no link with this complaint.Evaluation statement: the complaint device is not being returned; it was discarded by the customer and therefore is unavailable for a physical evaluation.A batch record 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 as related to the reported problem, and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.While the complaint event information indicates the anchor was possibly off axis to the bone hole during the insertion attempt which may have caused or contributed to the anchor breaking, 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.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.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 surgeon was doing a bankart repair and when trying to insert the tip of the anchor into the hole one side of the tip broke off.Retrieved the piece of the anchor that broke.Opened a new anchor and completed the case with no problems.The patient, a female estimated to be in her upper 20's to early 30's, had average bone quality.The patient had other surgeries in her past, a prior shoulder scope that did not involve any anchors, and a back surgery.This surgery remained arthroscopic after the complaint device broke.The procedure was extended 3 to 5 minutes due to the anchor breaking.The complaint device was removed and discarded.The sales rep stated that she believes the surgeon was off axis during insertion at the time the tip of the anchor broke.

• Brand Name: BIOKNOTLESS PLUS W/PANACRYL
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7715145
• Report Number: 1221934-2018-51167
• Device Sequence Number: 1015178
• Product Code: MAI
• UDI-Device Identifier: 10886705002115
• UDI-Public: 10886705002115
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2013

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: 07/31/2013
• Device Catalogue Number: 212725
• Device Lot Number: 3443260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2013
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1