MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. 7MM X 23MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-161
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	06/10/2021
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 the 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: screw broke.Customer complaint: patient is taken to surgery on (b)(6), 2021 for the reconstruction of the acl of the right lower limb; by dr.(b)(6).The reconstruction of the ligament is performed with a hamstring autograft, with a triplicate graft with a femoral diameter of 7.5mm and a tibial graft of 8mm with a length of 7mm.The technique that the dr performs is screw-screw.After performing the arthroscopy, the flexible guide is passed and a 7.5mm flexible drill is drilled for the femur with a 28mm tunnel and the tibia with an 8mm drill, the graft is passed, then having it in place, a nitinol guide is passed and place the 7x 23mm biosteon screw (reference: 234-010-161, batch: bs200102, fv: 2023-01-31), in which when inserting it the dr feels and hears a sound that when checking confirms that the part 3 screw parts, the dr performed extraction maneuver but the tip was difficult to extract and with kelly forceps and pulling the graft towards the distal part of the knee it is possible to remove the graft and the screw tip, the state of the graft is verified and it is decided to do again the tuner in the femoral anal lc but this time it was bicortical.Again the whole process is carried out and a dilator is passed, and at the time of passing a new screw; this one again breaks the tip but the doctor decides to continue screwing and the graft is fully fixed.After this, the tibia part is fixed, the dr confirms the stability of the ligament and the knee and the surgery is finished.Investigation findings are: screw broke due to technique used.No changes were made to the tunnel between attempts to insert the screws and as both screws of the same size broke this insinuates that the tunnel was not sized correctly, causing excess torque which led to the breakage.The feel and sounds shows that it was a sudden snap rather than gradual, which indicates use of excessive force and the screw becoming lodged in the tunnel.The screw broke into three parts indicating that the breakage will not have been along sealing lines.This is supported by the difficulty to remove the tip.Though the second screw also breaks it was still supporting the ligament stability, being fully fixed in the tunnel.Screw fragments from the first device usage were successfully removed from the tunnel.Warnings and precautions, including prevention of screw breakages are stated in the instructions for use.Surgery was completed successfully with another bisoteon screw, as the clinician was claimed to be familiar with use of the device.There were no negative consequences to the patient.The suspected root causes are: user method/ techniques used.The corrective action: surgery was completed successfully.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. 7MM 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: 12316602
• Report Number: 0002936485-2021-00426
• Device Sequence Number: 2696173
• Product Code: HWC
• UDI-Device Identifier: 15060155710249
• UDI-Public: 15060155710249
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2021

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: 234-010-161
• Device Catalogue Number: 234-010-161
• Device Lot Number: BS200102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 10/03/2021
• 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: 38 YR