MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222295

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 07/15/2022

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).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.Investigation summary : photos of the complaint device were received and evaluated.Upon visual inspection of the photos, the anchor appears to be cracked on the distal part of the tip; therefore, this complaint can be confirmed.The photo did not provide enough evidence to determine root cause.Without physical evaluation of the device reported, we cannot establish a root cause for the issue experienced by the customer.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 rev 26, pic-vs121 rev4, pic-vse0028 rev8.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-103161292 rev 2; the potential occurrence of having broken anchor for product code 222295 has been evaluated with 3; effect of having the anchor missing has been evaluated in the wi-6474 rev23 by combining probality and severity levels.3 complaints received over 109996 parts produced since 2016.With a ratio of 0.0036 % < 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.We have 100% control: we could not assemble with faulty anchor.A defective anchor is identified if there is one during 100% inspection.A record evaluation was performed for the finished device lot number: 8l87388, and no nonconformances were identified.Further, a review into the mitek complaints system revealed no other complaints for this lot of 298 devices that were released to distribution.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.

Event Description

It was reported by a healthcare professional in china that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the 4.5 healix advance br anchor with orthocord was cracked upon opening its package.During in-house engineering evaluation of the photos, it was determined through upon visual inspection that the anchor appeared to be cracked on the distal part of the tip.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be 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.H10 additional narrative: investigation summary: the complaint device was received and evaluated, upon visual inspection, it was found that the anchor is cracked on the distal part of the tip.The shaft and suture are in good condition.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 rev 26, pic-vs121 rev4, pic-vse0028 rev8.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-103161292 rev 2; the potential occurrence of having broken anchor for product code 222295 has been evaluated with 3; effect of having the anchor missing has been evaluated in the wi-6474 rev23 by combining probability and severity levels.3 complaints received over 109996 parts produced since 2016.With a ratio of 0.0036 % < 0.02% and is ranking 1 (= improbable and negligible); 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.We have 100% control: we could not assemble with faulty anchor.A defective anchor is identified if there is one during 100% inspection.Further, a review into the mitek complaints system revealed no other complaints for this lot of 298 devices that were released to distribution.A record evaluation was performed for the finished device lot number: 8l87388, and no nonconformances were identified.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.

• Brand Name: 4.5 HEALIX ADVANCE BR ANCHOR WITH ORTHOCORD
• Type of Device: 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: 15303451
• MDR Text Key: 305519704
• Report Number: 1221934-2022-02618
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021314
• UDI-Public: 10886705021314
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120078
• 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

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: 222295
• Device Catalogue Number: 222295
• Device Lot Number: 8L87388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/03/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 55 KG