MAUDE Adverse Event Report: AKROS MEDICAL, INC FIBULINK SYNDESMOSIS REPAIR KIT/ TI; WASHER, BOLT NUT

Model Number	FGS-1100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id also reported as (b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or 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 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 during a syndesmosis repair on (b)(6) 2020, the tension cap head of the fibulink syndesmosis repair kit broke off.The issue occurred when the surgeon was inserting the tension knob while attempting to insert the tibia link device through a titanium plate.Another fibulink kit was used instead.Procedure was completed successfully with no delay.There was no patient consequence.Concomitant devices: titanium plate (part: 441.371, lot: unknown, quantity: 1).This report is for a fibulink® syndesmosis repair kit.This is report 1 of 1 for (b)(4).
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.H4, h6: a device history record (dhr) review was conducted: part number: fgs-1100.Synthes lot number: 20e001.Supplier lot number: n/a.Release to warehouse date: 25jun2020.Expiration date: n/a.Supplier: (b)(4), inc.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.

• Brand Name: FIBULINK SYNDESMOSIS REPAIR KIT/ TI
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): AKROS MEDICAL, INC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10471795
• Report Number: 3013401747-2020-00005
• Device Sequence Number: 14271353
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: (01)00863176000317
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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-1100
• Device Catalogue Number: FGS-1100
• Device Lot Number: 20E001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/23/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TI LCP® ONE-THIRD TUBULAR PLATE
• Patient Age: 15 YR