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

Model Number	212722
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2013
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.Evaluation statement: the complaint anchor was received and visual observation confirms the anchor is broken.As reported, the observed failure is consistent with typical off axis insertion and using too much tension while inserting.This failure can be attributed to user technique.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 no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, 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.Udi: (b)(4).Associated medwatches: [mr#1221934-2018-51558]; [mr#1221934-2018-51563].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 repair that the tips on three of the customer's bioknotless rapide (br) anchor with orthocord broke upon insertion.The sales rep stated the anchors were still on the inserter at the time and the surgeon used too much tension.The sales rep stated the surgeon completely removed each broken anchor, prepped the bone hole again and inserted another like anchor in the same bone hole with no patient consequences but a 10 minute delay.The sales rep stated the surgeon was off-axis and used too much tension.The sales rep said the bone quality was hard and the patient was young but he had no further information.

• Brand Name: BIOKNOTLESS RAPIDE W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7697283
• Report Number: 1221934-2018-51562
• Device Sequence Number: 13706887
• Product Code: MAI
• UDI-Device Identifier: 10886705002085
• UDI-Public: (01)10886705002085(10)3704153(17)160531
• 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): 08/28/2013

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: 05/31/2016
• Device Model Number: 212722
• Device Catalogue Number: 212722
• Device Lot Number: 3704153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2013
• Initial Report FDA Received Date: 07/17/2018
• Patient Sequence Number: 1