MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP O-C VIOLET *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222980
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Event: it was reported during the procedure of dr.Patient (b)(6), at the hospital (b)(6), the lupine anchor (code: 222980 and lot 3874316) broke the wire and he could not be used it.Product information: 222980 and lot 3874316, four products were opened, one being quoted above.No injury to patient.
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.Evaluation statement: the complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed.Given the information provided, we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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).

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7722016
• Report Number: 1221934-2018-54203
• Device Sequence Number: 13713274
• Product Code: MAI
• UDI-Device Identifier: 10886705008582
• UDI-Public: 10886705008582
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 10/31/2018
• Device Catalogue Number: 222980
• Device Lot Number: 3874316
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 11/02/2018
• Patient Sequence Number: 1