MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FULLFLUTE REAM 8MM *EA; CANNULATED SURGICAL DRILL

Model Number 219342

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).The lot number is not currently available.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 3 of 3 for the same event.It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the tendonharv pigtail peeler ea device tore the graft and the procedure had to be cancelled.It was further reported that the restore fullflute ream 8 mm ea device was not able to cut, and another restore fullflute ream 12 mm ea device was used to try to make the tibial tunnel; however, it was in the same condition that it was not able to cut either.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

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.Additional narrative: additional information: udi: (b)(4).Event: subsequent follow-up with the customer, additional information was received.It was reported that the tenotome to take out graft reference: (b)(4) pigtail tendon peeler, was the one that arrived for this patient and tore the graft and this was one of the reasons why the second acl was canceled, since the other tenotome (gun type) had to be taken out that came on the other equipment.Furthermore, the tibial drill bits number 8 of the two equipments were without edge.It was reported that the other drill was also removed from the second equipment to try to make the tibial tunnel without passing so much difficulty but they were in the same conditions, references:(b)(4) and (10) (b)(4).One of the implants reference: (b)(4), arrived packed but without any contents inside the box.

Manufacturer Narrative

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.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, it was determined that the device was without edge.Therefore, the complaint reported was confirmed.It was determined that the photo did not provide enough evidence to determine the root cause.The possible root cause can be associate at excessive force or at normal wear of the device.However, it cannot be conclusively affirmed as hands-on analysis should provide the evidence necessary to confirm the root cause.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances 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.Device history lot : a manufacturing record evaluation was performed for the finished device lot/serial number 1601001, and no non-conformances were identified.

Event Description

This is report 3 of 3 for the same event.It was reported by the affiliate in colombia that during an unspecified surgical procedure, it was observed that the tendonharv pigtail peeler *ea device tore the graft and the procedure had to be cancelled.It was further reported that the restore fullflute ream 8mm *ea device was not able to cut, and another restore fullflute ream 8mm *ea device was used to try to make the tibial tunnel; however, it was in the same condition that it was not able to cut either.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

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.Correction: b5: event description: it was reported on the initial report that another restore fullflute ream 12mm *ea device was used to try to make the tibial tunnel.However, subsequent follow-up with the customer determined that it was a spare restore fullflute ream 8mm *ea that was used.Therefore, the event description have been updated to reflect this correct information.D1, d4: based on the correction reported by the customer, the brand name, catalog number, and udi have been updated accordingly to reflect the correct information.Therefore, udi: (b)(4).Additional information: d4: the lot number was reported as unknown in the initial report and has been updated accordingly based on the additional information from the reporter.Therefore, udi: (b)(4).

Manufacturer Narrative

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the second patient whose case was canceled was not under anesthesia because the lca equipment was used with the previous patient.

• Type of Device: CANNULATED SURGICAL DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9375493
• MDR Text Key: 203532528
• Report Number: 1221934-2019-59786
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886705005871
• UDI-Public: 10886705005871
• 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,Followup,Followup
• Report Date: 10/31/2019

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: 219342
• Device Catalogue Number: 219348
• Device Lot Number: 1601001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/23/2019; 01/29/2020; 01/30/2020; 02/24/2020
• Supplement Dates FDA Received: 12/24/2019; 01/30/2020; 01/31/2020; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1