MAUDE Adverse Event Report: STRYKER SPINE-US DECOMPRESSION TUBE SNAKE ARM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48080230
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a lite decompression tube snake arm 'would no longer clamp onto the tube dilator' outside the operating room.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
Visual inspection: it was observed that the distal lever/clamp had deformed.The circular feature of the clamp had flattened.Functional inspection: the device was functionally inspected using a sample decompression tube.The tube did not fit securely onto to clamp due to the deformation.The connection was unstable and the tube was moving.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.From ifu: 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.Per the sales rep, the device was lubricated, it has been used successfully previously and it was in sales rep possession for a few weeks.The instrument is distributed as loaners to multiple sales reps and the exact usage cannot be confirmed.Per manufacturing history review the product is in the field for approximately 2 years.The most likely cause of the reported event based on previous similar events and trend reports is wear after repeated use.
Event or Problem Description
It was reported that a lite decompression tube snake arm 'would no longer clamp onto the tube dilator' outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: DECOMPRESSION TUBE SNAKE ARM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11362634
• Report Number: 0009617544-2021-00019
• Device Sequence Number: 13662457
• Product Code: LXH
• UDI-Device Identifier: 07613327263909
• UDI-Public: 07613327263909
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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 Model Number: 48080230
• Device Catalogue Number: 48080230
• Device Lot Number: 192770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1