MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5 CANCELLOUS BONE SCREW 30MM; IMPLANT

Catalog Number 2030-6530-1

Device Problems Bent (1059); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 02/20/2015

Event Type  malfunction  

Event Description

During a primary tha, a screw bent very badly during implantation.The screw was removed.No delay in surgery and no adverse consequence to the patient.

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Manufacturer Narrative

Review of device history records indicates (b)(4) devices were manufactured and accepted into final stock on 18-aug-2014.There have been no other events for the lot referenced.Visual inspection: the reported event was confirmed.The head and first thread of the screw was bent.The user likely overtorqued the screw causing the observed damage.Conclusion: the investigation determined the user likely overtorqued the screw causing it to bend.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.

Event Description

During a primary tha, a screw bent very badly during implantation.The screw was removed.No delay in surgery and no adverse consequence to the patient.

• Brand Name: 6.5 CANCELLOUS BONE SCREW 30MM
• Type of Device: IMPLANT
• 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: 4617876
• MDR Text Key: 5658902
• Report Number: 0002249697-2015-00783
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K894124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 2030-6530-1
• Device Lot Number: MNMD06
• Other Device ID Number: STERILE LOT# MSHNM18A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2014
• 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
• Patient Age: 52 YR