MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON T BR DS ANCH W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210811
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/27/2019
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.(b)(4).
Event or Problem Description
It was reported by the affiliate via phone that during the arthroscopic labral repair of shoulder joint procedure, when insert the gryphon t br ds anch w/oc, the devices were broken off.Two of them remained in the patient, one broken part was removed from patient as the photo shows.Another device was used to complete the surgery.As the material is bio,there were no adverse consequences to the patient.The surgery time was not delayed.No additional information could be provided.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: the device will not be returned for evaluation.It remained implanted in the patient, therefore not available for evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination.Review conducted per qlik query executed 10-14-2019.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.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.

• Brand Name: GRYPHON T BR DS ANCH W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8910227
• Report Number: 1221934-2019-58046
• Device Sequence Number: 1606781
• Product Code: MAI
• UDI-Device Identifier: 10886705001255
• UDI-Public: 10886705001255
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 10/31/2021
• Device Catalogue Number: 210811
• Device Lot Number: 2L16211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1