MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 232447

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 09/30/2022

Event Type  malfunction  

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 not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).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 a healthcare professional in china that preoperatively to an anterior cruciate ligament reconstruction surgery on (b)(6) 2022, it was observed that a foreign matter hair was found inside the packaging of the rigidloop adjustable cortical implant, standard device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 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 not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device was returned and evaluated.The device comes in a completely sealed pouch.Upon visual inspection, a hair can be observed inside the pouch.This complaint can be confirmed.A manufacturing investigation was performed with the following results: 100% in production control is performed according to procedure.Visually inspect the pouches according to the associated procedures: pic-vse0028 rev8 and wi-ft0119 rev9.An in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also per wi-ft0118rev27, pic-vs121rev4 wi-ft0119 rev 9 and pic-vse0028 rev8.The result of this process check is successful, none of the 9 parts were non-conformed.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.Risk assessment: according to procedure sws-0380 rev:11 a 100% inspection of the scelling is performed by the boxing operator.It is clearly indicated in the wi-ft0119 rev:9, ¿inspection visuelle des particules " no hair is tolerated".The potential occurrence of having a hair inside the package has been evaluated to 2 over 232447 since 2019.Effect of having a hair in packing evaluated in the wi-6474 rev23 by combining probability and severity levels.With a ratio of 0.000 % < 0.02% and is ranking 2 (=minor ).This risk is acceptable.(b)(4).Complaint research, with the same defect did show 0 other case with this issue from 2018 to now with the item reference (b)(4): 5 nr was found during the research, but we found only 1 for the same defect.5 complaints received over 232447 parts produced since 2018, but not for the same defect.The analysis showed 100 % production controls implemented in the sterile level, as well as in process controls do guarantee 100% detection of this kind of problem if it was generated in neuchâtel.- this problem of a hair was found in packing in the pouch is an isolated event and the most likely assignable cause is human error.The bounding is limited on this part as the complaint analysis shows that there is no other occurrence of such defect for this batch, the batch before and the batch after.Based on the investigation performed and documented as part of this rationale, there is no specific event recorded in the dhr that could have generated quality (b)(4).However, the most probable assignable cause is a human error made by the operators who did work on the assembly process of 232447 lot 9l10870.An nc was opened to track this failure with the supplier ((b)(4)) a deeper investigation will be performed under this action.A manufacturing record evaluation was performed for the finished device 9l10870 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 result, this complaint can be confirmed.An nc was opened to track this failure with the supplier ((b)(4)) a deeper investigation will be performed under this action.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.

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 not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : the complaint device is not being returned, therefore unavailable for a physical evaluation, however a photo was provided.Upon visual inspection of the photo, a hair can be observed inside the pouch.A manufacturing investigation will be performed.A manufacturing record evaluation was performed for the finished device 9l10870 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.An nc was opened to track this failure with the supplier a deeper investigation will be performed under this action.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.

• Brand Name: RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT, STANDARD
• 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 (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15978647
• MDR Text Key: 307996793
• Report Number: 1221934-2022-03938
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705024094
• UDI-Public: 10886705024094
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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 Model Number: 232447
• Device Catalogue Number: 232447
• Device Lot Number: 9L10870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/02/2023; 02/03/2023
• Supplement Dates FDA Received: 01/03/2023; 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1