MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TOGGLELOC WITH ZIPLOOP INLINE; STAPLE, FIXATION

Model Number 110005087

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Tissue Injury (4559)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the surgeon fixed the tendon graft and when checking the graft fixation, he noticed that the graft was loose and the button came out and got stuck in the femoral tunnel.An osteotomy was planned to remove the button by the surgeon.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The button that came out and went into the femoral tunnel, was not coming out so the surgeon had to do an osteotomy and used the same tunnel for button removal.A new tunnel was not necessary as the surgeon was able to complete the procedure with the initial femoral tunnel.This event did not result in a serious injury.Furthermore, this event has not been previously reported for a serious injury.Therefore, the initial reports were forwarded in error and should be voided.

Event Description

Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The button that came out and went into the femoral tunnel, was not coming out so the surgeon had to do an osteotomy and used the same tunnel for button removal.A new tunnel was not necessary as the surgeon was able to complete the procedure with the initial femoral tunnel.This event did not result in a serious injury.Furthermore, this event has not been previously reported for a serious injury.Therefore, the initial reports were forwarded in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that the surgeon fixed the tendon graft and when checking the graft fixation, he noticed that the graft was loose and the button came out and got stuck in the femoral tunnel.An osteotomy was utilized to remove the button by the surgeon.The surgeon was able to use the same tunnel to implant a second device without issue.

• Brand Name: TOGGLELOC WITH ZIPLOOP INLINE
• Type of Device: STAPLE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14700243
• MDR Text Key: 294904827
• Report Number: 0001825034-2022-01408
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00880304567634
• UDI-Public: (01)00880304567634(17)240408(10)437440
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K130033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 110005087
• Device Catalogue Number: 110005087
• Device Lot Number: 437440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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 Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male