MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.5HLX ADV PK ANC-DYNA STR/BL; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222028

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown; therefore, the expiration date was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep in (b)(6) that during an unknown surgery on an unknown date, it was observed that the dynacord sutures in the ha applicator got caught so it was harder to take applicator away on the 4.5hlx adv pk anc-dyna str/bl device.The same device was used to complete the procedure with only a minute delay.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: according to the information received, it was reported that during rc repair, the dynacord sutures in the ha applicator get caught so that's harder to take applicator away.The complaint device is still implanted in the patient, therefore unavailable for a physical evaluation.Since the complaint device remains implanted, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.

• Brand Name: 4.5HLX ADV PK ANC-DYNA STR/BL
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 11507465
• MDR Text Key: 240632596
• Report Number: 1221934-2021-00885
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705029426
• UDI-Public: 10886705029426
• Combination Product (y/n): N
• PMA/PMN Number: K173859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2021

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
• Device Operator: Health Professional
• Device Model Number: 222028
• Device Catalogue Number: 222028
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/04/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1