MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STRYKER MODULAR IMPACT HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	2000-2000
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other 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
It was reported that the modular impact handle was prepared before operation, there were metal pieces that came out from the impact handle.The device was purchased by the hospital in (b)(6) 2018.The doctor inquired, where the metal pieces were scraped, how could such an event have occurred.
Additional Manufacturer Narrative
An event regarding a foreign matter found inside the triathlon impactor was reported.The event was confirmed.Method & results: device evaluation and results: the device was returned in good condition along with the foreign matter that came out from the inside of the handle.Material analysis inspection concluded "eds analysis was performed on the debris from the impactor handle.Elemental constituents included fe-cr-ni-cu, consistent with 17-4 ph stainless steel alloy." medical records received and evaluation: clinician review was not performed as there is no indication that the event was related to patient factors.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there have been no other events for the referenced lot.Conclusions: the root cause of the event was determined to be a manufacturing non-conformance.Nc was raised regarding a non-conforming modular handle, where metal shavings were found to fall out of the device manufactured by and inspected by metal craft.The nc stated that the supplier has identified that the most probable operation for shavings of this nature to occur in the their process is operation 102 - mill-turn cnc on assembly 6 during the manufacturing of the core subcomponent pn2000-2001-1, which is made of 17-4 ph ss material.
Event or Problem Description
It was reported that the modular impact handle was prepared before operation, there were metal pieces that came out from the impact handle.The device was purchased by the hospital in dec 2018.The doctor inquired, where the metal pieces were scraped, how could such an event have occurred.

• Brand Name: STRYKER MODULAR IMPACT HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8412078
• Report Number: 0002249697-2019-01298
• Device Sequence Number: 11323207
• Product Code: LXH
• UDI-Device Identifier: 07613327241938
• UDI-Public: 07613327241938
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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 Catalogue Number: 2000-2000
• Device Lot Number: 4303708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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