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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72201395
Device Problems Break (1069); Tip (3123)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/13/2019
Event Type  Malfunction  
Manufacturer Narrative

Foreign zip code: (b)(6).

 
Event 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.

 
Manufacturer Narrative

Patient age between 20 and 30 years.

 
Event 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.

 
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.

 
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Brand NameSPADE DRILL BIT FOR 2.9 ANCHOR
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key8425135
MDR Text Key139046719
Report Number1219602-2019-00310
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/02/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72201395
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/24/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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