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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AKROS MEDICAL, INC FIBULINK SYNDESMOSIS REPAIR KIT/SS; WASHER, BOLT NUT
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AKROS MEDICAL, INC FIBULINK SYNDESMOSIS REPAIR KIT/SS; WASHER, BOLT NUT Back to Search Results
Catalog Number FGS-1000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unk - drill bits: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).
 
Event Description
It was reported that on (b)(6) 2020, the cannulated drill bit broke off on the patient.Used screw removal set to extract a broken drill bit.No fragments generated.There were a 37 minutes surgical delay.The procedure successfully completed.No patient consequences.This complaint involves one (1) device.This report is for (1) unk - drill bits: trauma.This report is 1 of 1 for (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.H3, h4, h6: part number:fgs-1000, synthes lot number: 20e022, supplier lot number: n/a, release to warehouse date: november 11, 2020, expiration date: n/a, supplier: (b)(4).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.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 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.
 
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.
 
Event Description
This report is for one (1) fibulink® syndesmosis repair kit/ss.
 
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Brand Name
FIBULINK SYNDESMOSIS REPAIR KIT/SS
Type of Device
WASHER, BOLT NUT
Manufacturer (Section D)
AKROS MEDICAL, INC
eimattstrasse 3
oberdorf PA 4436
SZ  4436
MDR Report Key11133543
MDR Text Key225766182
Report Number2939274-2021-00078
Device Sequence Number1
Product Code HTN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFGS-1000
Device Lot Number20E022
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2021
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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