MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON PKR UNIVERSAL INSERT TRIAL 8MM-9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	I-K27280809
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock on with no relevant reported discrepancies.Based on the device identification the complaint databases were reviewed for similar reported events regarding crack/fracture.There have been no other similar events for the lot referenced.
Event or Problem Description
It broke when dr tried to pull out after inserting the insert trial.The nurse confirmed whether all broken parts were collected or not.After confirming that all debris was removed from the patient's body, the operation was continued.
Event or Problem Description
It broke when dr tried to pull out after inserting the insert trial.The nurse confirmed whether all broken parts were collected or not.After confirming that all debris was removed from the patient's body, the operation was continued.
Additional Manufacturer Narrative
Added expiration date.An event regarding crack/fracture involving a specialty trial was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were returned for review.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 were no other events for the lot provided.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as device return and the primary operative report are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: SPECIALTY TRIATHLON PKR UNIVERSAL INSERT TRIAL 8MM-9MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8195618
• Report Number: 0002249697-2018-04115
• Device Sequence Number: 1552926
• Product Code: LXH
• UDI-Device Identifier: 07613327305913
• UDI-Public: 07613327305913
• 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): 02/26/2019

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: 08/26/2021
• Device Catalogue Number: I-K27280809
• Device Lot Number: AP11A53
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/26/2019
• 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: 84 YR
• Patient Weight: 72