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

Model Number	I-K27280809
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Filler gauge cracked when it was used for checking the tension before the final insert selection.Broken part fit perfectly, so insert was placed after cleaning.
Event or Problem Description
Filler gauge cracked when it was used for checking the tension before the final insert selection.Broken part fit perfectly, so insert was placed after cleaning.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a specialty trial was reported.The event was confirmed by inspection of device.Method & results: - product evaluation and results: visual inspection of the returned device noted that the device was returned in used condition.The device is observed to be fractured in 2 parts, both parts were received.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition as indicated by hackles observed on fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional and functional analysis were not performed as the device was returned in fractured condition.- clinician review: 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: it was reported that the insert trial of the pkr instrument was damaged during surgery.Examination of the returned device with engineer indicated that the device is fractured due to an overload condition as indicated by hackles observed on fracture surface.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation for this event is possible at this time.If 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: 11730574
• Report Number: 0002249697-2021-00740
• Device Sequence Number: 11590422
• Product Code: LXH
• UDI-Device Identifier: 07613327305913
• UDI-Public: 07613327305913
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/30/2021

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: I-K27280809
• Device Catalogue Number: I-K27280809
• Device Lot Number: AP15A24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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