MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR, TWINFIX ULTRA, 4.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72202633

Device Problems Break (1069); Material Fragmentation (1261); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Broken shaft, an instrument broke during surgery.The surgeon drilled a hole, approximately 3mm, in the humerus for a biceps tenodesis further distal than the groove, possibly sub-pec.He then tapped the hole with the 4.5mm twinfix tap in preparation for a 4.5 twinfix anchor.The tap went all the way down and then broke as he started to unscrew it.A very small amount was sticking proud from the bone and the surgeon ended up removing the broken piece using pliers, drills, osteotomes which took approximately 50 minutes to retrieve.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicates that the drill utilized during the procedure was a facility owned competitor's device.The diameter of the drill used may have contributed to the incident occurring, not necessarily the depth of drilling.

Manufacturer Narrative

Visual assessment of the device showed the distal tip has broken off.No material voids were observed at the break area.The distal tip is heavily damaged at the break location, which likely took place during its removal from the patient¿s bone.The material condition was tested and found to be within print specifications.The device was inspected dimensionally; all attributes that could be accurately measured were found to be within print specifications.As reported the surgeon did not use the appropriate smith & nephew drill and guide to predrill the insertion site prior to tapping the site.Per the anchor ifu "using the appropriate smith & nephew drill bit and drill guide, prepare the anchor insertion site".A review of the device history record was performed which confirmed no inconsistencies.After the evaluation the root cause for the reported issue was determined to be user error.No further investigation is warranted at this time.(b)(4).

• Brand Name: AWL-DILATOR, TWINFIX ULTRA, 4.5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• 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: james gonzales ; 130 forbes boulevard; mansfield, MA 02048 ; 5123585706
• MDR Report Key: 5224693
• MDR Text Key: 31409722
• Report Number: 1219602-2015-01193
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72202633
• Device Lot Number: 50389457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR