MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HRIS FLEXIBLE OSTEO 12X93MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6210-0-740
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2019
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.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
The customer reported that the sterile packaged, single use item was rusty when the box was opened.Update: another item was opened to complete the case.
Additional Manufacturer Narrative
Reported event: an event regarding corrosion involving a hris flexible osteotome was reported.The event was confirmed via mar.Method & results: -product evaluation and results: the device including packaging was returned for evaluation.The unit carton was severely worn and torn.There are brown staining areas which is consistent with corrosion.A material analysis has been performed.The report concluded that eds showed that the surface feature on the osteotome was consistent with iron-oxide.Xrf showed that the base material of both components were consistent with 455ss and the hardness was measured to be 51 hrc, meeting the drawing min of 47 hrc.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the device including packaging was returned for evaluation.The unit carton was severely worn and torn.There are brown staining areas which is consistent with corrosion.A material analysis has been performed.The report concluded that eds showed that the surface feature on the osteotome was consistent with iron-oxide.Xrf showed that the base material of both components were consistent with 455ss and the hardness was measured to be 51 hrc, meeting the drawing min of 47 hrc.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The sqe and packaging sme reviewed the event and stated: "per the review of the stryker and phillips precision inc.Dhrs, the review of both the internal and supplier packaging and cleaning processes and the fact that there is rust on one unit out of a manufactured supplier lot of 126 pieces.It has been deemed that this complaint is not the result of a manufacturing defect and does not warrant escalation to a gqo nc.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be re-opened.
Event or Problem Description
The customer reported that the sterile packaged, single use item was rusty when the box was opened.**update** another item was opened to complete the case.

• Brand Name: HRIS FLEXIBLE OSTEO 12X93MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9197474
• Report Number: 0002249697-2019-03523
• Device Sequence Number: 409652
• Product Code: LXH
• UDI-Device Identifier: 07613327143935
• UDI-Public: 07613327143935
• 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): 11/24/2020

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: 03/31/2023
• Device Model Number: 6210-0-740
• Device Catalogue Number: 6210-0-740
• Device Lot Number: X18C18A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 11/24/2020
• 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