MAUDE Adverse Event Report: DEPUY MITEK LLC US BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	254624
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is report 3 of 3 for (b)(4).It was reported by a healthcare professional in china that during a knee procedure on (b)(6) 2023, it was observed that the suture on the truespan meniscal repair system peek 24 degree device broke off when tightened.Changed to another one to continue the surgery but it did not fire again after the first firing.According to the report, a foreign matter such as a hair was found when package of the bio-intrafix tapered screw, 7-9 mm x 30 mm device was opened.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information was provided.
Additional 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.
Additional 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, it was discarded, therefore unavailable for a physical evaluation, however four photos were provided.Upon visual inspection of the fourth photo, it was observed the device over its outer box, the device appear to be in a normal condition, also a foreign matter could be seen over the device, however the sterilized packaging is not shown in the photo.A manufacturing record evaluation was performed for the finished device 7l20928 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, this complaint can be confirmed.The manufacturer performed an investigation with the following results: an in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also pert tm-tme0091 rev 45 , the : pic-vs201rev:6 ,the ft-0119 rev :8 and the wi-ft0118 rev :24.The result of this process check is successful, none of the 9 parts were non-conformed.So, there is no need to inspect more parts of the batch nor raise a non-conformance.The batch was assembled by operators trained and certified on the process validated in production.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.It is clearly indicated in the wi-ft0119 rev:8, ¿inspection visuelle des particules " no hair is tolerated.The effect of ¿a hair /fiber was found ¿was evaluated in wi-6474 rev y by combining the probability and occurrence levels on 33 442.50 parts produced since 2020, with a ratio of 1 in 150,000, we obtain rank 2 (= improbable).This risk is acceptable.The analysis showed that the production controls implemented at the non-sterile level, as well as the in-process controls guarantee 100% detection of this type of problem if it was generated in neuchâtel.A 100% control of the particles of the part according to the wi-ft0119 rev:8 and an in-process control of 9 pieces taken randomly, guarantee that this type of defect does not occur in the manufacturing process.We can conclude that it is highly unlikely that this defect was generated during the manufacturing process.A manufacturing investigation activity was conducted to determine if there were any internal processing issues that may have contributed to the nature of the product complaint.A thorough review of production process controls was conducted.The results show that this batch of product was processed without incident.Nevertheless, there is no evidence of manufacturing anomalies.According to the technical drawing dwg-107357-mtk rev g, the size of the fiber/particle is smaller than the size of the pitch of screw and is smaller than the particle size tolerated in the procedure of wi-ft0119 rev 8.Based on the above, it is confirmed that the manufacturing process was performed in accordance with the validated processes.The root cause is not related to manufacturing.If the ¿a hair/ fiber was found¿, it cannot be related to a problem occurring during the manufacturing process, it must be related either to a bad handling by the user.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: BIO-INTRAFIX TAPERED SCREW, 7-9 MM X 30 MM
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16709426
• Report Number: 1221934-2023-01543
• Device Sequence Number: 14935093
• Product Code: HWC
• UDI-Device Identifier: 10886705013210
• UDI-Public: 10886705013210
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K032167
• 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,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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 254624
• Device Catalogue Number: 254624
• Device Lot Number: 7L20928
• 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: 03/22/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2020
• 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