MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 8MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number 234-010-162

Device Problems Break (1069); Entrapment of Device (1212); Fitting Problem (2183)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.Filing on behalf of oem biocomposites.

Event Description

It was reported that the screw broke and pieces were potentially remaining in the patient.

Event Description

It was reported that the screw broke and pieces were potentially remaining in the patient.

Manufacturer Narrative

The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: loose, does not fit well.According to biocomposites: investigation findings are: the use of the tarraja is considered an improper use of the medical device.Instructions for use must be understood and followed to allow the medical device to operate and function as desired/designed.The use of a tarraja weakened the screw, allowing it to break, leading to the loss of torque feeling.The suspected root causes are: improper use of the device, instructions for use not followed.The device manufacture date is not known.

• Brand Name: PKG. 8MM X 23MM STRYKER BIOSTEON SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11971467
• MDR Text Key: 255337385
• Report Number: 0002936485-2021-00308
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 15060155710256
• UDI-Public: 15060155710256
• Combination Product (y/n): N
• PMA/PMN Number: K003641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 234-010-162
• Device Catalogue Number: 234-010-162
• Device Lot Number: BS200306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 73