MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON MIS CAPTURED TIB. RES. GUIDE LEFT; GUIDE, SURGICAL, INSTRUMENT

Model Number	I-K4233KT0L
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2020
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.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the cross pin hole is not where it is supposed to be on custom tibia cutting blocks.Issue was noticed during a tka case.Rep confirmed that there was no surgical delay and that no further information would be released by the surgeon or hospital.
Additional Manufacturer Narrative
Corrected data: expiration date populated in error, in initial report.As the device is an instrument, it does not have an expiration date.Corrected data: labeled for single use.An event regarding position of cross pin hole involving specialty triathlon instrument was reported.The event was confirmed by inspection of returned device.Method & results: device evaluation and results: the device was returned in used condition.X-pin was at an oblique angle to the front surface of the specialty guide confirming the complaint.Dimensional, material analysis and functional analysis were not performed as these aspects were not in question.Clinician review: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: it was reported that the cross pin hole is not where it is supposed to be on custom tibia cutting blocks.This event is determined to be a manufacturing issue and an nc was issued on (b)(6) 2020 to investigate this event.Based on the review and comparison of 34 data points (dimensions), it was determined that the event is an isolated incident.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
It was reported that the cross pin hole is not where it is supposed to be on custom tibia cutting blocks.Issue was noticed during a tka case.Rep confirmed that there was no surgical delay and that no further information would be released by the surgeon or hospital.

• Brand Name: SPECIALTY TRIATHLON MIS CAPTURED TIB. RES. GUIDE LEFT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10340995
• Report Number: 0002249697-2020-01565
• Device Sequence Number: 3748814
• Product Code: FZX
• UDI-Device Identifier: 07613327503258
• UDI-Public: 07613327503258
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 11/19/2020

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: 02/28/2025
• Device Model Number: I-K4233KT0L
• Device Catalogue Number: I-K4233KT0L
• Device Lot Number: AP14V19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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