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 Code	Break (1069)
Health Effect - Clinical Codes	Tissue Damage (2104); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi:(b)(4).
Event or Problem Description
It was reported by the affiliate via email that during an achilles tendon repair on a patient whose diagnosis was rupture of the achilles tendon.The fastin rc 5.0 w/ocord w/ndls (1l76564) failed when putting the anchor and cutting the suture, the surgeon had to opened another fastin rc 5.0 w/ocord w/ndls (6l28722) that worked fine during the surgery, but at the next day the patient ad to re-enter the ward, because the 2nd anchor failed again but this time inside the patient body.The surgeon had to used products from the competitor.As per the affiliate the clinic advise they will be sending us a warning letter and they will also inform the corresponding authorities about the situation.
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: b5, h1: subsequent follow-up with the customer, additional information was received.It was reported that the patient went home after the initial surgery, and then had to come back for another surgery due to the failure of the first procedure.Since there was a revision surgery and a medical intervention, this complaint has been upgraded to a serious injury.H6: patient code: 3191 (no code available) was used to capture surgical intervention.
Additional Manufacturer Narrative
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: h6: method codes: device history lot: a manufacturing record evaluation was performed for the finished device [1l76564] number, and no non-conformances were identified.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [1l76564] number, and no non-conformances were identified.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.

• 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: 9588490
• Report Number: 1221934-2020-00193
• Device Sequence Number: 2387824
• Product Code: HWC
• UDI-Device Identifier: 10886705008698
• UDI-Public: 10886705008698
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 222991
• Device Catalogue Number: 222991
• Device Lot Number: 1L76564
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/04/2020; 02/25/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/07/2020; 02/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention