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.As per email communication, tap was used and tip of it broken intra-op.Majority of the broken fragments were retrieved.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.Device not returned.
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.As per email communication, tap was used and tip of it broken intra-op.Majority of the broken fragments were retrieved.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: 8149016
• Report Number: 0009617544-2018-00295
• Device Sequence Number: 11073820
• 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: UNKNOWN
• 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