MAUDE Adverse Event Report: STRYKER SPINE-US ES2 CANNULATED MODULAR TAP; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48280145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a "crack" was observed in the tip of an es2 cannulated modular tap during post-operative cleaning.Surgery had successfully been completed with the device and no delay.No fragments of the device were left in the patient.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual: visual inspection confirmed that the tip of the tap had fractured.Device history records were reviewed for this lot, and no relevant manufacturing issues.Complaint history records were reviewed for this lot, similar complaints were identified.The es2 surgical technique recommends that the awl is used to create a pilot hole prior to tapping.It was unconfirmed if an awl was used or not during this devices use.Event occurred pre-op, not during a procedure.The most likely root cause was determined to be the age of the device.Device was manufactured in 2013 and is over 7 years old.
Event or Problem Description
It was reported that a "crack" was observed in the tip of an es2 cannulated modular tap during post-operative cleaning.Surgery had successfully been completed with the device and no delay.No fragments of the device were left in the patient.No adverse consequences or medical intervention were reported.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11590494
• Report Number: 0009617544-2021-00050
• Device Sequence Number: 14647880
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 48280145
• Device Catalogue Number: 48280145
• Device Lot Number: B79273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR