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

Model Number	FGS-1100
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review investigation.Reporter is jnj representative.Investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
It was reported that on an unknown date, a couple of fibulink that break, the fgs-11, one of them won¿t tighten out.The other one, the actual head of the cap was broke.It is unknown if there was surgical delay reported.It is unknown if the procedure was successfully completed.It is unknown if there were fragments generated.The patient outcome was unknown.This complaint involves two (2) devices.This report is for (1) fibulink syndesmosis repair kit/ti this is report 1 of 2 (b)(4).

• 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: 11350585
• Report Number: 3013401747-2021-00015
• Device Sequence Number: 14464361
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: 00863176000317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173550
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

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: 9088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1
• Patient Age: 49 YR