MAUDE Adverse Event Report: STRYKER SPINE-US ES2 90 DEGREES ROD INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48280090
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an inserter would not disengage from rod.Surgeon disengaged lock screw and it would not release as it was hung up on the hex.A cobb was used to push it off an it would not release.Surgeon had to take the rod back out and increase the incision.The surgery was completed successfully.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via communication and visual inspection.Upon visual inspection, it was confirmed that the opening where the rod is inserted is deformed.Manufacturing history was reviewed and no issues were identified.The actual event led to increase in incision.A medical expert reviewed this complaint and concluded that increase in the incision does not poses serious harm to the patient.No surgical delay or adverse consequences to the patient is reported.Conclusion: based on observed wear and tear marks upon visual inspection and the age of the device (4 years), the plausible root causes of this event is normal wear and tear of instruments.
Event or Problem Description
It was reported that an inserter would not disengage from rod.Surgeon disengaged lock screw and it would not release as it was hung up on the hex.A cobb was used to push it off an it would not release.Surgeon had to take the rod back out and increase the incision.The surgery was completed successfully.

• Brand Name: ES2 90 DEGREES ROD INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7281700
• Report Number: 0009617544-2018-00047
• Device Sequence Number: 14028566
• Product Code: LXH
• UDI-Device Identifier: 07613327006964
• UDI-Public: (01)07613327006964
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: No Information
• Device Model Number: 48280090
• Device Catalogue Number: 48280090
• Device Lot Number: 138575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 84