MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5 HEALIX ADV SP PEEK CE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 228056

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/31/2022

Event Type  malfunction  

Event Description

It was reported by the affiliate in (b)(6) that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that upon opening the package of the 5.5 healix adv sp peek ce device, there were black mold spots throughout the packaging.Another like device was used to complete the procedure with a delay of one minute.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

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 lot number was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name and device manufacture date were 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.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was ot available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary
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> the device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received and photo provided by the customer.The visual inspection revealed that the tyvek pouch was unopened and had black spots over the pouch.The box received was damage.The same condition of the packaging was found during the physical evaluation.A manufacturing record evaluation was performed for the finished device lot number: 8l06080, and no nonconformances were identified.Based on the black spots; this complaint can be confirmed.A ft-ir (fourier transform infrared spectroscopy) test was performed by the manufacturer, the purpose of this analysis is to identify chemical composition.The results of the ftir showed that unknown stains over the pouch are composed by silicon-base material, however, source of origin cannot be ascertained.Mold was suspected by the customer, but the stains are unknown.A manufacturing investigation was performed; as a result, an in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also per tm-tme0091 rev48, wi-ft0118, picvse0029, pic-vse0028, pic-vs121.The result of this process check is successful, none of the 9 parts were non-conformed; there is no need to inspect more parts of the batch nor raise a non-conformance.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.According to the pfmea-103483572; the potential occurrence of having a foreign matter inside sterile package black foreign material for product code 228056 has been evaluated 0 to over 5223 since 2020, per wi6474 rev23 corresponding to defect over parts; effect of having the anchor cracked has been evaluated in the wi-6474 rev23 by combining probability and severity levels.With a ratio of 0 % < 0.02% and is ranking 1 (= improbable and negligeable); therefore, this risk is acceptable.Based on the above, it is confirmed that the manufacturing process has been performed according to the validated processes.The root cause is not manufacturing related.Knowing that there is a 100% visual inspection on the visual aspect of the pouch and on the visual aspect of the box, plus knowing that we do have additional inspection performed to guarantee that none of this issue happens in the manufacturing process, we can conclude that it is highly improbable these defects were generated during the manufacturing process.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.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.

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.H10 additional narrative: d4; the lot number, expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Udi: (b)(4).D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5.5 HEALIX ADV SP PEEK CE
• 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
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 3035526892
• MDR Report Key: 14106016
• MDR Text Key: 290464933
• Report Number: 1221934-2022-01162
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 228056
• Device Lot Number: 8L06080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/26/2022; 05/30/2022
• Supplement Dates FDA Received: 04/27/2022; 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1