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

Model Number	6278-9-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Threads broke.Update (b)(6) 2022: spoke to rep.Instrument was observed with thread damage during a revision of stryker hip implants.There was no surgical delay.Rep confirmed no further information will be released by the hospital or surgeon.
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.
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
Threads broke.Update 28/january/2022: spoke to rep.Instrument was observed with thread damage during a revision of stryker hip implants.There was no surgical delay.Rep confirmed no further information will be released by the hospital or surgeon.
Event or Problem Description
Threads broke update 28/january/2022: spoke to rep.Instrument was observed with thread damage during a revision of stryker hip implants.There was no surgical delay.Rep confirmed 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 through visual inspection of the returned device.Method & results: device evaluation and results: visual inspection of the returned device indicated that the threaded portion of the device has fractured off.There is no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: review of the device history records indicate 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 lot referenced.Conclusion: visual inspection of the returned device indicated that the threaded portion of the device has fractured off.There is no indication that the event was a result of a material integrity issue.The exact cause of the event cannot be confirmed as insufficient information was provided.Further information such as video/photographs of the event as it occurred as well as return of the device and primary operative reports are needed to complete the investigation for determining root cause.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: 13522392
• Report Number: 0002249697-2022-00236
• Device Sequence Number: 5247981
• Product Code: LXH
• UDI-Device Identifier: 07613327221626
• UDI-Public: 07613327221626
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2022

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: 10/31/2024
• Device Model Number: 6278-9-070
• Device Catalogue Number: 6278-9-070
• Device Lot Number: TDEY801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2019
• 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 Sex: Male