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

Model Number	I-K2710KB00
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9246937
• Report Number: 0002249697-2019-03632
• Device Sequence Number: 448690
• Product Code: HRY
• UDI-Device Identifier: 07613327258189
• UDI-Public: 07613327258189
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K172326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/01/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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