MAUDE Adverse Event Report: STRYKER SPINE-US AERO AL REVISION HOUSING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48921004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that an aero al revision housing was found to be broken upon receipt.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Event or Problem Description
A company representative reported that an aero al revision housing was found to be broken upon receipt.The reported event was noted during inspection.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.
Additional Manufacturer Narrative
The device was visually inspected and the seal between the handle and the handle shaft was confirmed to be broken.Device history records were reviewed for this lot and no relevant manufacturing issues were identified.A review of complaint history associated with the subject catalog and lot number was performed and no adverse trends were observed.A conclusive root cause cannot be established.Factors such as consistent use of the instrument throughout its lifetime may cause fatigue, leading to eventual breakage.

• Brand Name: AERO AL REVISION HOUSING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14291969
• Report Number: 0009617544-2022-00053
• Device Sequence Number: 1559634
• Product Code: LXH
• UDI-Device Identifier: 07613327273458
• UDI-Public: 07613327273458
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48921004
• Device Catalogue Number: 48921004
• Device Lot Number: 179873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown