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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. SABRE, SJ 3.0MM 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

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ARTHREX, INC. SABRE, SJ 3.0MM 7CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL Back to Search Results
Model Number SABRE, SJ 3.0MM 7CM
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/29/2020
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that during an arthroscopic surgery of the wrist the blades showed material abrasion on the joint and the blade tip broke off inside the joint of the patient.The surgeon reported that everything was retrieved out of the patient.The x-rays confirmed that there are not bigger parts left in the patient however it could be that minor fine metal fragments remained inside the patient which could not be found.No harm for patient, operator or third party was reported.The surgery was finished successfully with the same device as the breakage occurred at the end of the surgery.It was not necessary to switch the surgical technique or do a second surgery.
 
Manufacturer Narrative
Complaint confirmed.Visual inspection of the returned ar-7300sr identified warping along the cutting window of the outer tube hood.The distal tip of the inner tube had broken, and horizontal grooves consistent with sites of metal debris production were noted along the outer diameter of the distal tip.Corresponding grooves were also observed along the inner diameter of the outer hood.Resistance was noted when removing the inner tube from the outer, as the inner tube had sustained damage consistent with the application of prying/leveraging forces.Material analysis of both the outer and inner tubes of the returned ar-7300sr complaint device confirmed that the device met all as-received specifications.The observed conditions are consistent with user applied mechanical forces, such as by prying/leveraging the ar-7300sr against bone and/or hard tissue during use.
 
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Brand Name
SABRE, SJ 3.0MM 7CM
Type of Device
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10074792
MDR Text Key191558510
Report Number1220246-2020-01849
Device Sequence Number1
Product Code GFA
UDI-Device Identifier00888867041974
UDI-Public00888867041974
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/30/2024
Device Model NumberSABRE, SJ 3.0MM 7CM
Device Catalogue NumberAR-7300SR
Device Lot Number10329662
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 04/30/2020
Initial Date FDA Received05/20/2020
Supplement Dates Manufacturer Received04/30/2020
Supplement Dates FDA Received07/08/2020
Patient Sequence Number1
Patient Outcome(s) Other;
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