MAUDE Adverse Event Report: STRYKER SPINE-US ES2 CANNULATED MODULAR TAP; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48280145
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Foreign Body In Patient (2687)
Date of Event	11/20/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that jamshidi broke intra-op and 40mm of it stuck in the patient pedicle.The pedicle hole was enlarged to remove stuck jamshidi.Majority of the broken fragments were retrieved.As per email communication, tap was used and bone stuck.A surgical delay of 2 hours was reported.
Additional Manufacturer Narrative
Method: nc/capa history review, labelling review, risk assessment result: the reported event was confirmed via email correspondence.Device was not returned and lot # was not provided, therefore device evaluation and product history review could not be performed.Conclusion: without device evaluation and product information, root cause could not be determined.
Event or Problem Description
It was reported that jamshidi broke intra-op and 40mm of it stuck in the patient pedicle.The pedicle hole was enlarged to remove stuck jamshidi.Majority of the broken fragments were retrieved.As per email communication, tap was used and bone stuck.A surgical delay of 2 hours was reported.

• Brand Name: ES2 CANNULATED MODULAR TAP
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8148881
• Report Number: 0009617544-2018-00294
• Device Sequence Number: 19204306
• Product Code: NKB
• UDI-Device Identifier: 04546540710413
• UDI-Public: 04546540710413
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K140400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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 Catalogue Number: 48280145
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other