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

Catalog Number 72201395

Device Problem Break (1069)

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.

• Brand Name: SPADE DRILL BIT FOR 2.9 ANCHOR
• Type of Device: SAW, 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 Key: 8425135
• MDR Text Key: 139046719
• Report Number: 1219602-2019-00310
• Device Sequence Number: 1
• Product Code: HAB
• UDI-Device Identifier: 03596010595546
• UDI-Public: 03596010595546
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72201395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2019
• 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: Unknown
• Patient Sequence Number: 1