MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5 HEALIX3 PEEK ANC.W/OCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222207
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device was not returned; therefore, unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, it was found that the shaft of the device was detached from the handle while the anchor remained attached on the inserter tip, however, it was uncertain that the anchor was stuck due to the device was not returned.As no defect was found, a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the photo visual inspection result, this complaint cannot be confirmed.The customer is not sending the device for evaluation.The device is required for testing, the photo provided does not contain enough evidence to determine why the customer experienced the failure, hands on analysis should provide the required evidence to provide a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the customer in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the anchor could not be detached from the shaft on the 5.5 healix3 peek anc.W/ocord device.During in-house engineering evaluation of the photo provided by the customer, it was determined that the shaft of the device was detached from the handle while the anchor remained attached on the inserter tip.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 5.5 HEALIX3 PEEK ANC.W/OCORD
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13367045
• Report Number: 1221934-2022-00315
• Device Sequence Number: 11741064
• Product Code: MAI
• UDI-Device Identifier: 10886705007554
• UDI-Public: 10886705007554
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 05/31/2024
• Device Model Number: 222207
• Device Catalogue Number: 222207
• Device Lot Number: 8L25429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown