MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 5.5HLX ADV BR ANC-DYNA STR/BL; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	222004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
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.Udi:( (b)(4).The expiration date is currently unavailable.
Event or Problem Description
It was reported via email that a doctor experienced an issue a dynacord break.After following up with the sales rep via phone, he stated that during a rotator cuff procedure while the doctor was tying the half hitch knot, the dynacord broke.He did not think it needed to be reported since the break was where the doctor was going to cut the suture in the end.There were no patient consequences or delays.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device is implanted in the patient and will not be available for a physical evaluation.This complaint is not confirmed.It was reported that the suture broke during the tying of the half hitch knot.No information regarding the procedure or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of devices were processed with one incident.This event is not relevant to the complaint condition since it concern a qualification for assembly and vacuum drying process therefore, there is no evidence of manufacturing anomalies on the records reviewed.A review into the depuy mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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).

• Brand Name: 5.5HLX ADV BR ANC-DYNA STR/BL
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 7642471
• Report Number: 1221934-2018-52522
• Device Sequence Number: 2324395
• Product Code: MAI
• UDI-Device Identifier: 10886705029464
• UDI-Public: 10886705029464
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173859
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 01/31/2021
• Device Catalogue Number: 222004
• Device Lot Number: L736777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1