MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN 3.0MM #2 ETH *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	222130
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The exp date is currently unavailable.The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy 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 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 (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 affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the strands of fastin 3.0mm #2 eth *ea suture device snapped.According to the reporter, the event occurred when tensioning for the first know when it was inserted into the patient's anchor by hand.It was reported that the event occurred once the surgeon was satisfied with the depth of the anchor and began to tie the strands into knot.It was reported that the surgeon was able to complete the repair using loose sutures.It was reported that the suture broke above the anchor joint and not the joint interface.It was reported that after the breakage, the anchor was left in the patient to prevent any further damage to the bone and no other implants were used just a stay suture to complete the repair.It was not reported if there was a delay in the surgical procedure or if a spare device was used to complete the procedure.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).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Udi: (b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.This supplementary medwatch is being filed to capture complete udi no other changes are required.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8265002
• Report Number: 1221934-2018-52605
• Device Sequence Number: 19221113
• Product Code: JDR
• UDI-Device Identifier: 10886705007493
• UDI-Public: 10886705007493
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K945203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2016

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: 04/30/2021
• Device Catalogue Number: 222130
• Device Lot Number: 3906267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: 09/22/2016; 01/25/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 01/25/2019; 10/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1