MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #0 ETH OS-2 *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); Not Applicable (3189)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
It was reported that during the lateral malleolus ligament repair surgery, when tied the knot, the suture was broken,removed the anchor with 3-0 absorbable suture to replace the broken suture to complete the surgery.The surgery delayed about 30 minutes.The patient is stable and in hospital now.
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.Additional information: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Investigation summary : the complaint device was received and evaluated.Visual observations confirms that the suture was broken.A root cause for the reported failure cannot be discerned.However, based on the fraying on the suture, it is possible that an instrument used in the procedure caused this failure.A manufacturing record evaluation was performed for the finished device [l883109] number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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.Device history lot : a manufacturing record evaluation was performed for the finished device [l883109] number, and no non-conformances were identified.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9446801
• Report Number: 1221934-2019-59922
• Device Sequence Number: 19489602
• Product Code: MAI
• UDI-Device Identifier: 10886705001972
• UDI-Public: 10886705001972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2019

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: 04/30/2023
• Device Model Number: 212133
• Device Catalogue Number: 212133
• Device Lot Number: L883109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 02/04/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/23/2019; 02/04/2020
• Patient Sequence Number: 1