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

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.

• 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 Key: 10074792
• MDR Text Key: 191558510
• Report Number: 1220246-2020-01849
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867041974
• UDI-Public: 00888867041974
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Date: 06/30/2024
• Device Model Number: SABRE, SJ 3.0MM 7CM
• Device Catalogue Number: AR-7300SR
• Device Lot Number: 10329662
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 04/30/2020
• Supplement Dates FDA Received: 07/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other