MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 9MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-163
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the screw broke during the procedure and potentially remained in the joint.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.This investigation will be closed based on probable root cause.Alleged failure: graft remaining loose.Customer complaint: "in the procedure of acl and pcl, semitendinus graft is prepared, a 9mm drill and tarraja is passed, a 9 * 23 screw is passed, the dr begins to feel resistance, but maintains the strength and keeps trying to place it when the half had been twisted part of the graft remaining loose so the doctor fixes it with a cortical screw.Investigation findings are: the clinic at which this took place was servi medical.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 corrective action: n/a.The preventive action: n/a." the failure mode will be monitored for future reoccurrence: manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that the screw broke during the procedure and potentially remained in the joint.

• Brand Name: PKG. 9MM X 23MM STRYKER BIOSTEON SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 12318552
• Report Number: 0002936485-2021-00427
• Device Sequence Number: 14579854
• Product Code: HWC
• UDI-Device Identifier: 15060155710263
• UDI-Public: 15060155710263
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K003641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 234-010-163
• Device Catalogue Number: 234-010-163
• Device Lot Number: BS200102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 70