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	11/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap fractured off inside the patient's right l3 vertebral body intra-operatively.Subsequently, fixation was skipped at that level.The procedure was completed successfully with a 5 minute surgical delay.
Event or Problem Description
It was reported that the tip of an es2 cannulated modular tap fractured off inside the patient's right l3 vertebral body intra-operatively.Subsequently, fixation was skipped at that level.The procedure was completed successfully with a 5 minute surgical delay.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were not reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed per the device catalog number, no adverse trends were observed.Initial report states that the tip of the cannulated 4.5mm tap broke off inside the vertebral body.The tip was left in the pedicle and a screw was placed in the same hole.Procedure completed with no additional issues.It was reported that tapping was not done at a difficult angle and without excessive force.It is unknown how long device has been used.Patient had normal bone quality.Due to no lot# provided and no product return, a root cause could not be determined conclusively.Potential causes include but are not limited to: age of device (normal wear), age of device (pre design change), sclerotic or metastasized bone, and/or excessive force applied.H3 other text : status and location of the device is unknown.

• 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
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13026533
• Report Number: 0009617544-2021-00237
• Device Sequence Number: 12123121
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48280145
• Device Catalogue Number: 48280145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown