MAUDE Adverse Event Report: STRYKER SPINE-US TL INSERTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	580220100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint history was reviewed and there are no similar complaints for this lot number.The inserter was returned for evaluation and inspected visually, functionally, and dimensionally.The inserter was tested with two pressure gauges and it was unable to pressurize the system.Leakage was noticed from the area where the inserter mates with the pressure gauge.Destructive dimensional analysis was performed and the diameter of the inserter bore feature, where the pressure gauge mates with the inserter, was observed to be out of specification.Inserters in inventory were functionally tested and none resulted in the reported failure mode.It was concluded that the cause of the reported event was an out of specification bore diameter in the inserter.A non-conformance was initiated to investigate the root cause associated with this failure mode.
Event or Problem Description
It was reported that during intra-operative cage expansion a tritanium tl inserter would not hold pressure to expand the implant and began to leak during use.There were no adverse consequences to the patient and the procedure was completed successfully with a 10 minute surgical delay.
Event or Problem Description
It was reported that during intra-operative cage expansion a tritanium tl inserter would not hold pressure to expand the implant and began to leak during use.There were no adverse consequences to the patient and the procedure was completed successfully with a 10 minute surgical delay.
Additional Manufacturer Narrative
Stryker initiated a voluntary recall on 17 march 2021 and an urgent medical device recall letter was sent to the affected customers notifying them of the product issue and associated risks and providing instructions pertaining to the removal and return of the product to stryker.

• Brand Name: TL INSERTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11275986
• Report Number: 0009617544-2021-00013
• Device Sequence Number: 12001761
• Product Code: LXH
• UDI-Device Identifier: 07613327366884
• UDI-Public: 07613327366884
• 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: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: 580220100
• Device Catalogue Number: 580220100
• Device Lot Number: 195158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3004024955-3/11/2021001R
• Patient Sequence Number: 1