MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 5.0 W/OCORD W/NDLS; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	222991
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during shoulder arthroscopy procedure, it was observed that the sutures on the fastin rc 5.0 w/ocord w/ndls device were frayed and looked different.Then when the surgeon wanted to tie the sutures, they broke while being used for a fixation of a ligamentum.There was a delay in the surgery for 20-30 minutes due to opening a new device, and reimplanting the anchor.The surgery was completed with same like product as alternative product was readily available.There were no patient consequences reported and no surgical intervention planned.It was reported that the user was trained and the product was stored according to labeling instructions.No additional information was provided.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (3l87764), and no non-conformance was identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.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: FASTIN RC 5.0 W/OCORD W/NDLS
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10263909
• Report Number: 1221934-2020-01794
• Device Sequence Number: 2345530
• Product Code: HWC
• UDI-Device Identifier: 10886705008698
• UDI-Public: 10886705008698
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 03/31/2022
• Device Model Number: 222991
• Device Catalogue Number: 222991
• Device Lot Number: 3L87764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/10/2020
• Patient Sequence Number: 1