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

Model Number	72204988
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the tip of the drill broke off and was left inside the patient.A backup device was available to complete the procedure with no significant delay or patient injuries.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10.H3, h6: one microraptor drill used for treatment, was not returned for evaluation.Due to product unavailability, conclusions were limited.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Per instructions for use: ¿for single use only.This product is warranted to be free from defects in material and workmanship.Do not reuse.Prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.¿ instructions for use includes specific instructions, recommendations and precautionary statements for proper use of product.Factors that may affect device performance include: device storage/transit, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: 1.Getting entangled up with other instruments or devices.2.Use of other than recommended smith and nephew drill.3.The primary cutting edges of the drill are not sharp or have dings and burrs.4.Stressed product from over torque or loss of axial alignment.5.Inadvertent reuse of single use product.Review of instruction for use documentation confirmed instructions, precautionary statements and recommendations for proper use of product.Complaint history review indicated no similar allegations for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.Product met specifications upon release to distribution.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.

• 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: 9380814
• Report Number: 1219602-2019-01491
• Device Sequence Number: 10882549
• Product Code: MAI
• UDI-Device Identifier: 00885556710296
• UDI-Public: 00885556710296
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/07/2020

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: 09/27/2023
• Device Model Number: 72204988
• Device Catalogue Number: 72204988
• Device Lot Number: 50760345
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1