MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG ASSY, 4.5MM FLEXIBLE REAMER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	E
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
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 tag medical.
Event or Problem Description
It was reported that the device broke during the procedure and pieces remained in the patient.
Event or Problem Description
It was reported that the device broke during the procedure and pieces remained in the patient.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: reamer broke.Probable root cause: cannot be determined, as tag is unable to provide investigation report without the device to evaluate.The device manufacture date is not known.H3 other text: 81.

• Brand Name: PKG ASSY, 4.5MM FLEXIBLE REAMER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11741162
• Report Number: 0002936485-2021-00233
• Device Sequence Number: 19859115
• Product Code: LXH
• UDI-Device Identifier: 10810190016067
• UDI-Public: 10810190016067
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: E
• Device Catalogue Number: 234-108-045
• Device Lot Number: 19P01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/08/2021
• 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