MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 8MM X 28MM STRYKER BIOSTEON SCREW; SCREW, FIXATION, BONE

Model Number	234-010-165
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
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 post-operatively and required a revision surgery.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.Please note stryker is not the legal manufacturer of the device on this investigation.According to biocomposites: investigation findings are: more information has been requested from (b)(4).Due to the limited amount provided.(b)(4) from stryker informed us that they would be filling a serious injury mdr due to the screw seemingly breaking post-operatively, requiring a revision surgery.Biocomposites reported this event to the materiovigilance programme of india (mvpi) with the ministry of health and family welfare on 24th june 2021, with receipt acknowledged on 1st july 2021.Despite numerous attempts to attain more information, stryker received no response from the reporting customer.As such there is not enough information to launch an investigation and it is not possible to determine the root cause.Most likely an unforeseen event has occurred involving the patient, such as trauma to the surgery area, rather than a shortcoming in device design, as to our knowledge this is the first case of a broken biosteon screw being removed post-operatively.Another possibility is that the screw was broken by the surgeon at time of insertion, which went unnoticed, however this is hypothetical.The suspected root causes are: not possible to determine based on evidence provided.The corrective action: none implemented.The preventive action: n/a.The reported 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 post-operatively and required a revision surgery.

• Brand Name: PKG, 8MM 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
• MDR Report Key: 12004720
• Report Number: 0002936485-2021-00323
• Device Sequence Number: 4305835
• Product Code: HWC
• UDI-Device Identifier: 15060155710287
• UDI-Public: 15060155710287
• 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): 08/03/2021

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: No Information
• Device Model Number: 234-010-165
• Device Catalogue Number: 234-010-165
• Device Lot Number: BS190801
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: 31 YR