MAUDE Adverse Event Report: AKROS MEDICAL, INC FIBULINK REMOVAL KIT; WASHER, BOLT NUT

Model Number	FGS-1300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot part number:fgs-1300.Synthes lot number: 20e005.Supplier lot number: n/a.Release to warehouse date: 24jun2020.Expiration date: n/a.Supplier: (b)(6).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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.
Event or Problem Description
It was reported that on an unknown date, the fibulink syndesmosis repair kit and fibulink removal kit did not engage internal threads.It was unknown if there was a surgical delay.The procedure outcome was unknown.There was no patient consequence.This complaint involves two (2) devices.This report is for one (1) fibulink® removal kit.This is report 2 of 2 for (b)(4).
Event or Problem Description
It was reported that during an open reduction internal fixation (orif) of the ankle on (b)(6) 2020, the fibulink syndesmosis repair kit and fibulink removal kit did not engage internal threads.The procedure was completed by using a regular 3.5 cortex screw.There was no surgical delay and no patient consequence reported.
Additional 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.H10: additional narrative: b3, b5, d10.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 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.H10 additional narrative: e1: facility information updated.G3: updated.H6: updated.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.

• Brand Name: FIBULINK REMOVAL KIT
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): AKROS MEDICAL, INC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10770770
• Report Number: 3013401747-2020-00013
• Device Sequence Number: 1721041
• Product Code: HTN
• UDI-Device Identifier: 00863176000324
• UDI-Public: (01)00863176000324
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2020

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: FGS-1300
• Device Catalogue Number: FGS-1300
• Device Lot Number: 20E005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/03/2020; 12/21/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/31/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FIBULINK® SYNDESMOSIS REPAIR KIT/SS