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

Model Number	48280165
Medical Device Problem Codes	Material Deformation (2976); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital retained device.
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap was "no longer sharp" intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully without surgical delay.
Event or Problem Description
Upon additional information received from the filed representative, it was confirmed that the tip of the es2 cannulated modular tap was dull and not fractured as previously reported.
Additional Manufacturer Narrative
Upon additional information received from the filed representative, it was confirmed that the tip of the es2 cannulated modular tap was dull and not fractured as previously 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: 10440116
• Report Number: 0009617544-2020-00139
• Device Sequence Number: 14108097
• Product Code: LXH
• UDI-Device Identifier: 04546540710437
• UDI-Public: 04546540710437
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/17/2020

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: 48280165
• Device Catalogue Number: 48280165
• Device Lot Number: 111641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1