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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An event regarding crack/fracture involving a restoration modular separator was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Body stem separator 6278-9-070 broke while being used in surgery.The surgeon was able to remove on his own without any damage to patient.New proximal body was used and cup liner revised too.Update: this pi is for the intra-operative instrument breakage.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a restoration modular separator was reported.The event was confirmed via review of the returned device.Conclusion: it was reported that during the process of separating the restoration modular body from stem the stem separator broke.Visual inspection of the returned device indicated that a component of the tip has fractured off.The fractured piece was not returned.The exact cause of the event could not be determined because insufficient information was provided.If further information becomes available or the product is returned, this investigation will be re-opened.
Event or Problem Description
Body stem separator 6278-9-070 broke while being used in surgery.The surgeon was able to remove on his own without any damage to patient.New proximal body was used and cup liner revised too.Update: this is for the intra-operative instrument breakage.

• 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: 8358737
• Report Number: 0002249697-2019-01130
• Device Sequence Number: 16194775
• Product Code: LXH
• UDI-Device Identifier: 07613327221626
• UDI-Public: 07613327221626
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/31/2022

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: 12/31/2022
• Device Model Number: 6278-9-070
• Device Catalogue Number: 6278-9-070
• Device Lot Number: TDEWA00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• 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: Unknown