MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXPANDING HUMERAL INSERT TRIAL - SMALL 40MM CONSTRAINED; INSTRUMENT

Catalog Number 5901-SM-40IC

Device Problems Break (1069); Fracture (1260); Sticking (1597); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Resetting trays and noticed trial was stuck on baseplate trial.The plastic trial broke when i twisted it off baseplate.On (b)(6) 2014: further clarification from the sales rep indicated that the trial became stuck on the baseplate during an in-service.Upon further manipulation to remove the trial from the baseplate, it broke.The sales rep confirmed that it did not occur during surgery.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Not available.

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A visual inspection confirms the event.The post of the plastic trial was completely fractured off.Gouging was observed along the helical locking tract.The device was discovered during inspection; there was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.An analysis of the returned device found the device fractured due to a multiple impact overload condition.No material or manufacturing defects.No further investigation is required at this time.

Event Description

Resetting trays and noticed trial was stuck on baseplate trial.The plastic trial broke when i twisted it off baseplate.On 10-13-2014: further clarification from the sales rep indicated that the trial became stuck on the baseplate during an in-service.Upon further manipulation to remove the trial from the baseplate, it broke.The sales rep confirmed that it did not occur during surgery.

• Brand Name: EXPANDING HUMERAL INSERT TRIAL - SMALL 40MM CONSTRAINED
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4222219
• MDR Text Key: 4971491
• Report Number: 0002249697-2014-04127
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5901-SM-40IC
• Device Lot Number: ER7TH8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other