MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HRIS FLEXIBLE OSTEO 6X67MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6210-0-720
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2018
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 reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that as they unpackaged the grays osteotome prior to the case they noticed that there was fleck of corrosion on the coner.
Additional Manufacturer Narrative
An event regarding corrosion involving an hris osteotome was reported.Conclusion: the device was discovered during set up for surgery.The event was confirmed however, the root cause cannot be determined.The material analysis report indicated, "debris was observed on the osteotome.The location of the debris was at or near the weld between the blade and hex fitting of the osteotome.Eds showed the base alloy of the osteotome was consistent with 455 ph stainless steel alloy and the debris was consistent with iron oxide and the osteotome base alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined." however, based on the procedures and dhr's provided by the supplier and internal packaging team there were no deviations processing this instrument.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
The customer reported that as they unpackaged the grays osteotome prior to the case they noticed that there was fleck of corrosion on the corner.

• Brand Name: HRIS FLEXIBLE OSTEO 6X67MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7992221
• Report Number: 0002249697-2018-03465
• Device Sequence Number: 19146173
• Product Code: LXH
• UDI-Device Identifier: 07613327143898
• UDI-Public: 07613327143898
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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 Catalogue Number: 6210-0-720
• Device Lot Number: X18M27D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 05/20/2019
• 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