MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BOX CHISEL; CHISEL, SURGICAL, MANUAL

Catalog Number	6541-4-709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Box osteotome from triathlon set broke while cutting the box.Finished cut with saw.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon box chisel was reported.The event was confirmed through material analysis of the returned device.Method & results: product evaluation and results: visual inspection was performed as part of the material analysis report (mar), dated 26 july 2019 which indicated that the box chisel fractured into two components; the main body and the blade.The blade portion was analyzed further using a scanning electron microscope.The fracture originated near the letter ¿s¿ marked on the surface of the chisel and propagated through the thickness of the device.The ductile and mixed mode morphologies observed on the surface of the chisel, indicate that the devices fractured in overload likely from off axis loading.Energy-dispersive spectroscopy (eds) analysis was performed on the box chisel.The mar indicated the box chisel broken in overload likely from an off-axis loading condition.Eds showed that the base material was consistent with 17-4 ph.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the box chisel fractured into two components; the main body and the blade.The blade portion was analyzed further using a scanning electron microscope.The fracture originated near the letter ¿s¿ marked on the surface of the chisel and propagated through the thickness of the device.The ductile and mixed-mode morphologies observed on the surface of the chisel, indicate that the devices fractured in overload likely from off-axis loading.Energy-dispersive spectroscopy (eds) analysis was performed on the box chisel.Eds showed that the base material was consistent with 17-4 ph.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Box osteotome from triathlon set broke while cutting the box.Finished cut with saw.

• Brand Name: BOX CHISEL
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8749452
• Report Number: 0002249697-2019-02443
• Device Sequence Number: 16561116
• Product Code: FZO
• UDI-Device Identifier: 07613327179347
• UDI-Public: 07613327179347
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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 Expiration Date: 09/30/2009
• Device Catalogue Number: 6541-4-709
• Device Lot Number: PYE10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 09/19/2019
• 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: 64 YR
• Patient Weight: 85