MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PROXIMAL ROD ASSEMBLY - JAPAN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7650-1956
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
During the operation, a part to be driven into the tibial plateau in the proximal part of the product was broken.The debris has been collected.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a scorpio other instrument was reported.Visual inspection of the returned device confirmed the event.Method & results: product evaluation and results: visual inspection of the returned device noted the following: examination of the returned device with engineer indicated that this product has damage consistent with that described in capa related to pin fracture.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been 2 other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
During the operation, a part to be driven into the tibial plateau in the proximal part of the product was broken.The debris has been collected.

• Brand Name: PROXIMAL ROD ASSEMBLY - JAPAN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8250596
• Report Number: 0002249697-2019-00200
• Device Sequence Number: 11122559
• Product Code: LXH
• UDI-Device Identifier: 07613327234022
• UDI-Public: 07613327234022
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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: 7650-1956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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