MAUDE Adverse Event Report: ARTHREX, INC. SABRE, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	SABRE, 4.0MM X 13CM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional 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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during knee arthroscopy surgery the shaver blade did break off.The broken off piece has been retrieved from the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.No further information received.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-8400sr sabre was received for investigation.Visual inspection identified that the shaft of the returned ar-8400sr had broken into two distinct pieces, with the breakage sites of both pieces noticeably bent.Additionally, damage was present to the proximal end of the shrink tubing, also indicating that the device had been leveraged.The spring retainer was bent, and it could not be manually straightened out.Based on the evidence observed, the damage to the ar-8400sr is consistent with prying/leveraging against bone and/or hard tissue during use.

• Brand Name: SABRE, 4.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12300872
• Report Number: 1220246-2021-03505
• Device Sequence Number: 14498532
• Product Code: GFA
• UDI-Device Identifier: 00888867043633
• UDI-Public: 00888867043633
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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 Expiration Date: 08/31/2025
• Device Model Number: SABRE, 4.0MM X 13CM
• Device Catalogue Number: AR-8400SR
• Device Lot Number: 11758948
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1