MAUDE Adverse Event Report: DEPUY MITEK LLC US BIOKNOTLESS RAPIDE W/OC; 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	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported by the affiliate in (b)(6) that during a labral repair- shoulder stabilisation, the tip of their bioknotless rapide anchor broke while being implanting.Surgeon stated that the implant was inserted at shallow angle and not fully seated in bone causing tip to break on impact.Jnj representative was not present at this time, but jnj representative was present during removal of suture and tip.It was reported that the wound searched for remnants and irrigated.Action taken to manage the issue during the procedure: removal of remnants and thorough irrigation using shaver suction.Following exploration of joint to locate tip of implant.There was a 20 minute delay to procedure.The surgeon made the decision that the anchor would be required to come in from a shallow angle and that it would not be possible to implant it into the originally intended bone.Therefore the procedure was completed without attempting another implant and an additional bone hole.It was reported that the surgeon left the original bone hole, instead deciding that the repair was satisfactory without another anchor.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Additional 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 device was discarded by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part 212722 lot l736639 combination and no nonconformances were identified.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.Udi: (b)(4).

• 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: 8150955
• Report Number: 1221934-2018-55639
• Device Sequence Number: 11175883
• Product Code: MAI
• UDI-Device Identifier: 10886705002085
• UDI-Public: 10886705002085
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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: 01/31/2021
• Device Catalogue Number: 212722
• Device Lot Number: L736639
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1