MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, 1.9MM, S, DISPOSABLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 72203856

Device Problem Metal Shedding Debris (1804)

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

Event Date 11/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has not yet been returned.Due to the device not being returned, we are unable to determine what may have caused the user to experience the reported incident.No further investigation is necessary at this time.In the event the sample is returned for evaluation the complaint will be reopened for additional investigation.(b)(4).

Event Description

Reportedly, during a shoulder stabilization procedure the surgeon identified excess metal type debris in the shoulder.It was reported that hole preparation in the bone followed the standard technique using a crown tip drill guide with no issues noted during the drilling.On removal of drill and prior to inserting the anchor the surgeon identified excess metal type debris in the shoulder.The joint was flushed with saline using the pump and razor cut shaver to assist with the removal of the debris.Following debris removal the implant was successfully placed.The spike tip drill guide and the same drill were used for the second implant hole preparation and no debris was identified.

Manufacturer Narrative

Evaluation narrative - one 1.9mm disposable s drill for suturefix anchors was returned for evaluation.Visual assessment of the drill showed multiple contact points at the drill tip and proximal to the depth stop.The drill appears to have come in contact with the drill guide during use.This condition is consistent with alignment not being maintained during drilling resulting in the reported shedding.Dimensional assessment of the drill found it to meet print specifications.Guides were returned on 1/28/2016.Three crown tip drill guides were returned.Dimensional assessment found each guide met print specifications.Visual assessment of sample (a) showed the shaft is bent and the tip shows a contact point with material missing.Samples (b) and (c) showed no abnormalities.It appears that during the drilling process the guide became bent causing a misalignment which resulted in the shedding.No further investigation is warranted at this time.(b)(4).

• Brand Name: DRILL, 1.9MM, S, DISPOSABLE
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 5252998
• MDR Text Key: 32258381
• Report Number: 1219602-2015-01227
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2019
• Device Catalogue Number: 72203856
• Device Lot Number: 50527126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other