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

Catalog Number	212722
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	10/29/2015
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 device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints 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.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes 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.A review of the device history record indicated that this batch of product was re-boxed since the box was found to be damaged.Apart from that, this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Udi: (b)(4).This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep reported that during a lateral repair procedure when the doctor was drilling and inserting the tip of the customer's bio-knotless rapide br with orthocord, it was observed that the device broke off in the bone hole.The sales rep stated that the doctor removed the broken tip from the bone hole without any issues.The sales rep reported that the surgeon completed the procedure with another like device using the same bone hole.The sales rep reported that there were no patient consequences but there was a minute delay in the case.The sales rep stated that the patient's bone quality was very hard bone.The sales rep stated that the device was discarded.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: BIOKNOTLESS BR ANCHOR W/OTHOCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7864254
• Report Number: 1221934-2018-50905
• Device Sequence Number: 1263314
• Product Code: MAI
• UDI-Device Identifier: 10886705002085
• UDI-Public: 10886705002085
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 212722
• Device Lot Number: 3753221
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2015
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1