MAUDE Adverse Event Report: STRYKER SPINE-US MIS DECOMPRESSION TUBE 18MM X 5CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48081805
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, a circular part of the mis decompression tube, indicating its length, came off inside patient.This did not cause an adverse consequence to the patient, and the component was successfully removed.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence with the sales rep.The product was not returned.Device history review was not performed as the parts and/or lot was not provided.The general instrument ifu states that the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.It was confirmed that facility had this instrument for 3 years and used more than 100 times.Conclusion: the possible root cause is determined to be normal wear and tear of instrument.Device not returned.
Event or Problem Description
It was reported that during a procedure, a circular part of the mis decompression tube, indicating its length, came off inside patient.This did not cause an adverse consequence to the patient, and the component was successfully removed.

• Brand Name: MIS DECOMPRESSION TUBE 18MM X 5CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7974727
• Report Number: 0009617544-2018-00241
• Device Sequence Number: 1395250
• Product Code: LXH
• UDI-Device Identifier: 07613327264166
• UDI-Public: 07613327264166
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 48081805
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1