MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212722
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The batch review 3608665 showed that the devices were conformed to in process and finished goods specifications when released to stock the 23 apr.2012.Expiration date: 2015-04 (according to retained labels).No nc was opened.Memo was opened relating to deals with the inspection of the sutures assembly of bioknotless products, with no link with this complaint.Evaluation statement: the complaint device is not being returned, 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 and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 1 similar complaint 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.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 sales rep reported that during a shoulder repair that his bioknotless rapide (br) anchor with orthocord broke upon insertion.The sales rep stated the surgeon was off-axis.The anchor was still on the inserter and broke in the middle.The surgeon completely removed the broken anchor and inserted another like anchor in the same bone hole.The surgeon completed the procedure with no patient consequences or delay.The sales rep stated the male patient had good bone quality.The sales rep did not know of any preexisting medical conditions or mediation the patient was taken no further information was available.

• Brand Name: BIOKNOTLESS RAPIDE (BR) W/ORTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7687599
• Report Number: 1221934-2018-51305
• Device Sequence Number: 11091731
• Product Code: MAI
• UDI-Device Identifier: 10886705002085
• UDI-Public: 10886705002085
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/07/2013

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: 04/30/2015
• Device Catalogue Number: 212722
• Device Lot Number: 3608665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2013
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1