MAUDE Adverse Event Report: DEPUY MITEK LLC US TENDONHARV PIGTAIL PEELER *EA; TENDON STRIPPER

Model Number	232002
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that the extractor (stripper) burst the doctor's graft.The doctor has complained several times about this item.The procedure was a knee arthroscopy.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Furthermore, no lot number was supplied which precludes conducting a device history record (dhr) review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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.Udi: (b)(4).Depuy synthes has been informed that the lot number is not available.
Event or Problem Description
Additional information received from affiliate on 31october2018: it was noted the harvested tendon could still be used; it caused a little difficulty, but the surgeon could complement the issue and finish the procedure.The surgeon had to revert the technology to another method to finalize, but the final was not impacted, and the procedure was completed.It was noted there was a surgical delay due to the change of technique but the length of the delay was not provided.The size of the standard stripper of the box is very fine and may have contributed to the issue.

• Common Device Name: TENDON STRIPPER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7288914
• Report Number: 1221934-2018-50208
• Device Sequence Number: 2301438
• Product Code: LXH
• UDI-Device Identifier: 10886705010899
• UDI-Public: (01)10886705010899(10)1001120019
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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 Model Number: 232002
• Device Catalogue Number: 232002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1