MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MICRORAPTOR DRILL; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204988
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that drill was shedding metal debris during labral repair procedure.Debris was removed from the patient with shaver.No procedural delay or patient injury was reported.
Additional Manufacturer Narrative
One microraptor drill was returned for evaluation.Visual assessment of the drill confirmed the reported shedding.The first two distal centering lobes show visible signs of material galling.The shaft also shows an abrasion approximately 2.335 from the distal end of the chucking connector.The chucking connector also shows abrasions and flaking of the molded material on the underside of the depth stop.No root cause related to the manufacturing process could be established.Further investigation is not warranted at this time.

• Brand Name: MICRORAPTOR DRILL
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7823513
• Report Number: 1219602-2018-01134
• Device Sequence Number: 13774853
• Product Code: MAI
• UDI-Device Identifier: 00885556710296
• UDI-Public: (01)00885556710296(17)230625(10)50743472
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: 06/25/2023
• Device Catalogue Number: 72204988
• Device Lot Number: 50743472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR