MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SPECIALTY TRIATHLON GAP BALANCER-SIZER; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number I-K2710KB00

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.

Event Description

Central processing department staff notified me that gap balancing instrument was missing a small screw on the front of it, causing the lock feature to not work on it.Noticed it while putting it into a kit.No patient involvement.

Manufacturer Narrative

An event regarding missing component involving triathlon specialty instrument was reported.Conclusion: the device was returned and missing a small screw on the front was confirmed.The device was discovered during inspection.The reported device was returned for evaluation.Visual inspection was performed.Nothing remarkable to report.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.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 Description

Central processing department staff notified me that gap balancing instrument was missing a small screw on the front of it, causing the lock feature to not work on it.Noticed it while putting it into a kit.No patient involvement.

• Brand Name: SPECIALTY TRIATHLON GAP BALANCER-SIZER
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9246937
• MDR Text Key: 186802428
• Report Number: 0002249697-2019-03632
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 07613327258189
• UDI-Public: 07613327258189
• Combination Product (y/n): N
• PMA/PMN Number: K172326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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
• Device Operator: Health Professional
• Device Model Number: I-K2710KB00
• Device Catalogue Number: I-K2710KB00
• Device Lot Number: GEN9E801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other