MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK ANCHOR WITH THREADER TAB; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	210800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro-codes: gam; gas; gat; mbi; new.A review of the device history record: device history lot no non-conformance's were identified for this part number, lot number combination per qlik query executed on 8/12/2019.Device history batch null, device history review null.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.No non-conformance's were identified for this part number, lot number combination per qlik query executed on 8/12/2019.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.
Event or Problem Description
Device report from synthes mitek reports an event in (b)(6) as follows: it was reported that this was an unknown procedure performed on (b)(6) 2019.When the surgeon was threading the suture to the anchor (210800), the wire broke.The procedure was completed less than a 30-minute delay.There was no harm to the patient.The device was brand new and the first use when the issue occurred.This report is 1 of 1 for (b)(4).

• Brand Name: VERSALOK ANCHOR WITH THREADER TAB
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8962602
• Report Number: 1221934-2019-58188
• Device Sequence Number: 2399526
• Product Code: HWC
• UDI-Device Identifier: 10886705001163
• UDI-Public: (01)10886705001163
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 02/28/2022
• Device Catalogue Number: 210800
• Device Lot Number: 3L39782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/04/2019
• Patient Sequence Number: 1