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	05/29/2013
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.The complaint devices used in the procedure were not returned for evaluation to mitek complaints and therefore we cannot confirm this complaint.However, three unused, unopened devices from customer¿s inventory were received and evaluated.Visual observation under magnification reveals no structural anomalies on the anchor.The assembly of the anchor is in accordance with the specs.Two out of the three anchors were deployed into a sample test foam successfully.As reported in the case, the anchors were tapped into the test hole and presented no structural damage.It was reported that the anchor placement was not off axis.From the information available, we cannot discern a root cause for this failure.A lot review was conducted and 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 no other complaints of any kind for this lot of devices that were released to distribution.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.
Event or Problem Description
The sales rep reported that during a shoulder procedure two of the customer's bioknotless rapide br w/orthocord broke during insertion.The sales rep reported that the surgeon did not use any unusual angles, that he drilled the bone hole first, and then used the hole finder next.The surgeon then used a mallet to insert the anchor 1/2 way into the bone hole then tapped the anchor in to finish inserting the anchor the rest of the way in when it broke into pieces.The surgeon repeated the procedure with another like device to the same exact effect, breaking into pieces once half way inserted.Both anchors were fully removed.Both anchors were of the same lot number.The surgeon completed the procedure with a third like device but different lot number, with no patient consequences.There was a 10 minute delay in the procedure.The sales rep stated that the surgeon had used mitek products a long time.The sales rep removed three remaining unopened, unused anchors from the customer that were of the same lot number and is returning these for evaluation.Please see also medwatch report 1221934-2018-50971.

• 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: 7788340
• Report Number: 1221934-2018-50970
• Device Sequence Number: 2336888
• Product Code: MAI
• UDI-Device Identifier: 10886705002085
• UDI-Public: 10886705002085
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/29/2013

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: 01/01/2016
• Device Catalogue Number: 212722
• Device Lot Number: 3666409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2013
• Initial Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1