MAUDE Adverse Event Report: ARTHREX, INC. SHAVERDRILL 3.0MM KNOTLESS SUTURETAK,HB; BIT, DRILL

Model Number	SHAVERDRILL 3.0MM KNOTLESS SUTURETAK,HB
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/29/2019
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 device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during a shoulder arthroscopy with labral repair procedure the ar-1938dsr shaverdrill 3.0 mm suturetak shed metal shavings all over while being used for insertion of ar-1938bc.The rep stated the shaverdrill was being used for bone preparation for insertion of a quantity two ar-1938bc, and the device shed both times.The surgeon was able to clean out the metal shavings with the shaver, and the case was completed as planned.However, it cannot be confirmed if all metal shavings were fully removed.The rep stated the case was completed without adding significant time to the procedure, and without compromising patient safety.The shaverdrill was used with the ar-1946 durable drill guide.The bone quality was medium, and the flow of irrigation was not interrupted during use.The device was discarded and will not be returning for evaluation.There are no available pictures.Dualwave inflow being used was ar-6410 (lot: 33699482), and outflow ar-6430 (lot: 33955737).

• Brand Name: SHAVERDRILL 3.0MM KNOTLESS SUTURETAK,HB
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9081272
• Report Number: 1220246-2019-01322
• Device Sequence Number: 2775334
• Product Code: HTW
• UDI-Device Identifier: 00888867269064
• UDI-Public: 00888867269064
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: SHAVERDRILL 3.0MM KNOTLESS SUTURETAK,HB
• Device Catalogue Number: AR-1938DSR
• Device Lot Number: 10112397
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other