MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR; SAW, POWERED, AND ACCESSORIES

Catalog Number	72201395
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during surgery, drill tip broke and remained in patients bone as unable to retrieve.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
Patient age between 20 and 30 years.
Event or Problem Description
It was reported that during hip arthroscopy labral repair, drill tip broke and remained in patients bone as unable to retrieve.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
One 72201395 spade drill bit for 2.9 anchor returned.The complaint stated: ¿drill tip broke during use, drill remained in patients bone as unable to retrieve.¿ the drill bit was returned with the distal tip severed.The distal piece was not returned.The fracture location indicates forceful twist and over torque factors.The condition is consistent with the rotations seizing and therefore the instrument snapped.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.There are no other complaints for this lot.At this time the allegation is considered an isolated incident.

• Brand Name: SPADE DRILL BIT FOR 2.9 ANCHOR
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8425135
• Report Number: 1219602-2019-00310
• Device Sequence Number: 1147647
• Product Code: HAB
• UDI-Device Identifier: 03596010595546
• UDI-Public: 03596010595546
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/02/2019

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 Catalogue Number: 72201395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/03/2019; 04/04/2019; 05/01/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/03/2019; 04/04/2019; 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1