MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+#0 OC OS-2; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212849
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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).The lot number is unknown.
Event or Problem Description
T was reported by affiliate via complaint submission tool, that during an unknown procedure, when the nurse took out a minilok qa+ w/ #0 ocord and os-2 needle w/bit, the anchor was separated from the body.No surgical delay or patient consequence reported.
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Correction: upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: MINILOK QA+#0 OC OS-2
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9619104
• Report Number: 1221934-2020-00275
• Device Sequence Number: 585697
• Product Code: MAI
• UDI-Device Identifier: 10886705002382
• UDI-Public: 10886705002382
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2020

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 Model Number: 212849
• Device Catalogue Number: 212849
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/11/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 01/29/2020
• Patient Sequence Number: 1