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

Catalog Number	48280145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an mis t lift, the tap would not advance.The tap was removed and the tip of it was missing.The pieces were in the body.Hour and half surgical delay to remove pieces, some pieces remained inside the body.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via visual inspection.The device was inspected and it was found that the tip of the tip is fractured off, the fractured piece was not returned as it remains inside the patient.No adverse consequences to the patient were reported at this time.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be more than 4 years old.Conclusion: capa was opened to address this issue and includes a design change that increases the thickness of the tap and updating the surgical technique requiring use of the awl prior to tapping that has now been implemented for devices manufactured after 15aug2015.The reported device is in the scope of the capa.The probable root cause of the reported event is design related, based on the capa, es2 taps were identified to have lower wall thickness: the wall thickness of the lower diameter taps are more susceptible to fracture or normal wear and tear of instruments.
Event or Problem Description
It was reported that during an mis t lift, the tap would not advance.The tap was removed and the tip of it was missing.The pieces were in the body.Hour and half surgical delay to remove pieces, some pieces remained inside the body.

• 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: 7381683
• Report Number: 0009617544-2018-00074
• Device Sequence Number: 1095187
• Product Code: LXH
• UDI-Device Identifier: 04546540710413
• UDI-Public: (01)04546540710413
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K122845
• 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): 06/13/2018

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 Catalogue Number: 48280145
• Device Lot Number: 13A874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 05/15/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1