MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL GRYPHON P BR ANC-DYNACORD BL; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	210120
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189); No Code Available (3191)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
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
It was reported by the sales rep via email that during a bankart repair procedure two gryphon double suture anchors with dynacord cracked in half during implantation.Two other gryphon anchors with dynacord also split into pieces during the case.No fragments were left in the patient.The case was delayed thirty to forty minutes due to the anchor malfunctions.Additional surgical intervention was required, a new bone hole had to be created.The anchors were discarded into the sharps container by the customer.The procedure was completed with spare devices of the same product.
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.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination per qlik query executed on 06/10/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.No nonconformances were identified for this part-lot number combination per qlik query executed on 06/10/2019.

• Brand Name: GRYPHON P BR ANC-DYNACORD BL
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 8684015
• Report Number: 1221934-2019-57315
• Device Sequence Number: 2207267
• Product Code: MAI
• UDI-Device Identifier: 10886705029877
• UDI-Public: 10886705029877
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 08/31/2021
• Device Catalogue Number: 210120
• Device Lot Number: 1L38287
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1