MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 12 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228151

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: according to the information provided, it was reported that the product presented problems.The complaint device was received and evaluated; visual inspection reveals that the red trigger is broken.The plastic sleeve was removed to verify the presence of both plates, the plates were found inside the applier needle.The device was opened to verify the broken part, it was found that the upper part of the red trigger is broken.A manufacturing record evaluation was performed for the finished device 7l66393 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection and the functional test result, this complaint can be confirmed.A possible root cause can be attributed to a portion of tissue that was entered inside the applier needle causing a mechanical obstruction of the first plate when it was going to be deployed; this obstruction and the force applied to the trigger are contributive factors of the broken trigger, however this cannot be conclusively determined.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Event Description

It was reported by the affiliate in (b)(6) that the truespan 12 degree peek device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the upper part of the red trigger on the device was broken.There was no procedure nor patient involvement reported.No additional information was provided.

• Brand Name: TRUESPAN 12 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13001897
• MDR Text Key: 285170115
• Report Number: 1221934-2021-03723
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026012
• UDI-Public: 10886705026012
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 228151
• Device Catalogue Number: 228151
• Device Lot Number: 7L66393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1