MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 9MM X 28MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-166
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the screw broke during the procedure and remained in the patient.
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.
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.As per oem this complaint investigation "as this is a broken screw complaint in india, no final report will be generated and it will be folded into the ccon-00006 investigation."."based on our investigation work thus far, it is heavily indicated that user/technique is the primary contributing factor for these broken screws.As the oem supplier, we are initiating a full capa.This will result in the following: future broken screw complaints originating from india will be logged as feedback only and added to the capa as no investigation will be completed whilst this capa is open.No final report emails will be issued as a result." 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 remained in the patient.

• Brand Name: PKG, 9MM X 28MM STRYKER BIOSTEON SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15496220
• Report Number: 0002936485-2022-00544
• Device Sequence Number: 17664961
• Product Code: HWC
• UDI-Device Identifier: 15060155710294
• UDI-Public: 15060155710294
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K003641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: 234-010-166
• Device Catalogue Number: 234-010-166
• Device Lot Number: BS200501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown