MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BODY/STEM SEPARATOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	6278-9-070
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other 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
It was reported that during a revision of the patient's left hip, after inserting the body/ stem separator and turning, a pop was heard but the proximal cone body would not release.Turning continued and a second pop was heard.Surgeon elected to perform osteotomy and it was observed that the proximal body was separated.The surgeon reported that the bony on-growth had prevented the cone body from being removed.Body/ stem separator was observed to be broken.All pieces were removed from the patient.Procedure was completed successfully with a delay of 20-30 minutes.Rep confirmed that no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that during a revision of the patient's left hip, after inserting the body/ stem separator and turning, a pop was heard but the proximal cone body would not release.Turning continued and a second pop was heard.Surgeon elected to perform osteotomy and it was observed that the proximal body was separated.The surgeon reported that the bony on-growth had prevented the cone body from being removed.Body/ stem separator was observed to be broken.All pieces were removed from the patient.Procedure was completed successfully with a delay of 20-30 minutes.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a restoration modular separator was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the device has fractured in the threaded portion where the components mate.Additional damage is present on the device indicative of in-service use and contact against a hard object.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate devices were manufactured and accepted into final stock between with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the restoration modular separator broke during surgery.Visual inspection of the returned device indicated that the device has fractured in the threaded portion where the components mate.Additional damage is present on the device indicative of in-service use and contact against a hard object.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 reopened.

• Brand Name: BODY/STEM SEPARATOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15823517
• Report Number: 0002249697-2022-01668
• Device Sequence Number: 6109345
• Product Code: LXH
• UDI-Device Identifier: 07613327221626
• UDI-Public: 07613327221626
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 03/31/2019
• Device Model Number: 6278-9-070
• Device Catalogue Number: 6278-9-070
• Device Lot Number: TDEPA00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male