MAUDE Adverse Event Report: DEPUY MITEK LLC US TENDON HARV CLOSED STRIPPER EA; BONE TREPHINE

Model Number 254730

Device Problems Degraded (1153); Dull, Blunt (2407)

Patient Problems Tissue Damage (2104); Not Applicable (3189); Unspecified Tissue Injury (4559)

Event Date 10/31/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.Udi: (b)(4).

Event Description

It was reported by affiliate via complaint submission tool that while harvesting the semitendinosus tendon(tendon harv closed stripper ea), the tendon tear prematurely so the tendon was too short to use as a replacement for the acl reconstruction.The surgeon complain that a part of this problem was that the stripper was not sharp enough.Surgeon had to harvest a part of the tractus iliotibialis.30 minutes delay.No patient consequences.The device is available for evaluation.

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.Investigation summary =according to the information provided, it was reported that while harvesting the semitendinosus tendon, the tendon tear prematurely so the tendon was too short to use as a replacement for the acl reconstruction.The surgeon complain that a part of this problem was that the stripper was not sharp enough.Surgeon had to harvest a part of the tractus iliotibialis.The complaint device was received and evaluated.Visual observation reveals that the device is in normal use conditions, no structural damages could be found.The markings on the shaft are legible.The shaft is not bent.When reviewing at the distal tip of the device, it could be observed that the tip is dull.According with the visual inspection result, this complaint can be confirmed.This failure can be attributed to fair wear and tear of the device due to repeated use and sterilization cycles.A manufacturing record evaluation was performed for the finished device [19e01] number, and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

Manufacturer Narrative

Product complaint # (b)(4).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.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.Udi:(b)(4).

• Brand Name: TENDON HARV CLOSED STRIPPER EA
• Type of Device: BONE TREPHINE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10843366
• MDR Text Key: 216345441
• Report Number: 1221934-2020-03490
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705013739
• UDI-Public: 10886705013739
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 254730
• Device Catalogue Number: 254730
• Device Lot Number: 19E01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Manufacturer Received: 11/01/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/07/2020; 12/20/2020
• Supplement Dates FDA Received: 12/08/2020; 12/21/2020
• Patient Sequence Number: 1