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

Catalog Number	6278-9-070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Right hip, revision of competitor implants.It was reported that a metal piece broke off of the devices during surgery.All pieces were retrieved and the case was completed successfully with a delay of approximately 1-2 minutes.Update on 26 october, 2023, wg: rep reported that the trial body removal device was damaged during trialing of the proximal body.After implantation of the final implant, surgeon decided he wanted a different version on the proximal body.The body/ stem separator was damaged when trying to remove the first proximal body.
Additional Manufacturer Narrative
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.H3 other text : device not returned to the manufacturer.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18082030
• Report Number: 0002249697-2023-01347
• Device Sequence Number: 12695050
• Product Code: LXH
• UDI-Device Identifier: 07613327221626
• UDI-Public: 07613327221626
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 11/07/2023

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 Catalogue Number: 6278-9-070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2023
• Initial Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female