MAUDE Adverse Event Report: STRYKER SPINE-US MIS DECOMPRESSION TUBE DILATOR 2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Model Number	48080012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the surgeon was inserting the 12mm dilator, and the top of the dilator came off and fell onto the patient.The surgeon then put the piece on the mayo stand and continued to insert the other dilators.The surgeon was able to complete the case.No adverse consequences to the patient is reported.
Additional Manufacturer Narrative
The event was confirmed upon visual inspection of the returned device.The dilator ring was found missing from the tip of the dilator.However, the ring that got disengaged was not returned therefore further analysis could not be performed on the ring.The event did not lead to any adverse consequences to the patient.Manufacturing history was reviewed and no issues were identified.The device is approximately 2.5 years old.The exact root cause could not be determined due to incomplete return of the device components.Some of the plausible root causes include: normal wear and tear, instrument impacted during use that damaged the ring or the shaft, multiple heating and sterilization processes that results in losing the integrity of the connection/press fit.
Event or Problem Description
It is reported that the surgeon was inserting the 12mm dilator, and the top of the dilator came off and fell onto the patient.The surgeon then put the piece on the mayo stand and continued to insert the other dilators.The surgeon was able to complete the case.No adverse consequences tot he patient is reported.

• Brand Name: MIS DECOMPRESSION TUBE DILATOR 2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7318975
• Report Number: 0009617544-2018-00062
• Device Sequence Number: 109888
• Product Code: LXH
• UDI-Device Identifier: 07613327263992
• UDI-Public: (01)07613327263992
• 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,Followup
• Report Date (Section B): 06/26/2018

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: 48080012
• Device Catalogue Number: 48080012
• Device Lot Number: 14C879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1