MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; ARTHROSCOPIC BUR

Model Number 375-941-000

Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2014

Event Type  Injury  

Event Description

It was reported that the "tomcat burr/blade broke off inside the patient." an x-ray was taken in order to locate the burr/blade.The procedure was completed successfully without any adverse consequences to the patient.

Manufacturer Narrative

The complaint device was returned to stryker sustainability solutions (sss) for an evaluation.The returned device revealed presence of biological material on the distal tip and minor burrs to the distal tip of the outer shaft.Inspection of the proximal end of the inner part confirmed the reported issue as it was broken.The results of the investigation performed substantiated the reported issue as the inner hub was broken.Since appropriate inspections and testing are in place to ensure that devices are able to connect to the hand piece and function properly prior to leaving stryker sustainability solutions and the package was received open, with evidence of use, potential causes for the broken inner hub were determined to be: during clinical use of the device; the material of the device hub may have been stressed when the device was activated, initiating and propagating the crack which resulted in the returned condition of the device; or an internal om material deformation may have been present in the inner shaft hub which may have contributed to the reported issue.The reported event will continue to be monitored through post-market surveillance.A review of the lot control sheet (lcs) indicated that all required inspections and tests were conducted on all arthroscopic shavers in the lot in question indicating that the instrument was in working condition when released from stryker® sustainability solutions.The instructions for use (ifu) for arthroscopic shavers (as) states the following applicable warning related to this failure mode: "do not allow the arthroscopic shaver to come into contact with staples, clips or any metal object to avoid damage to the blade and possible patient injury." "careful handling of the instrument is necessary to avoid damage or breakage as a result of excessive force." "do not apply excessive pressure or ¿side-load¿ the blade during use.Side-loading does not improve the performance of the instrument, can dull the blade, and/or produce metal particulate.".

• Brand Name: NA
• Type of Device: ARTHROSCOPIC BUR
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer (Section G): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• Manufacturer Contact: moira barton varty ; 1810 w. drake drive; tempe, AZ 85283 ; 8888883433
• MDR Report Key: 4214841
• MDR Text Key: 18930477
• Report Number: 0001056128-2014-00125
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 375-941-000
• Device Catalogue Number: 375-941-000RR
• Device Lot Number: 2727317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention