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

Model Number	6210-0-720
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The customer reported that they opened a grays osteotome and it was damaged.The case was completed by opening another device.
Event or Problem Description
The customer reported that they opened a grays osteotome and it was damaged.The case was completed by opening another device.
Additional Manufacturer Narrative
Reported event: an event regarding damage involving hris flexible osteo 6x67mm was reported.The event was confirmed.Method & results: device evaluation and results: a material analysis has been performed.The report concluded: this inspection indicated the distal tip of the osteotome had been deformed.The damage present on the tip of the osteotome is consistent with contact against a hard object.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: the investigation concluded that the damage present on the tip of the osteotome is consistent with contact against a hard object.The cause of the damage could not be determined.Eds showed that the drill is consistent with 455 ph stainless steel and the hardness of 51hrc meets the drawing requirement.Based on the given information no materials discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• 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: 9459221
• Report Number: 0002249697-2019-04015
• Device Sequence Number: 3066346
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 09/30/2022
• Device Model Number: 6210-0-720
• Device Catalogue Number: 6210-0-720
• Device Lot Number: X17N60E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 03/23/2020
• 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