MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM VERSE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	299704270
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device not returned for evaluation.
Event or Problem Description
L5-s1 posterior lateral interbody fusion.Device is used as a two part device.Threaded inserter 2997 04 272 jammed in 2997 04 270 while surgeon was using.Tabs on pedicle screw were broken, and reduction instruments were needed to perform reduction technique.Flex clip was attached onto top notch of pedicle screw.Threader inserter then inserted into flex clip to perform reduction, while winding down on black reducer handle, a crack was heard.No more insertion was possible.Reduction was not performed , surgeon wound out 2997 04 272.Flex clip 2997 04 270 was unclipped from pedicle screw using a bone rongeuer.Piece of 2997 04 272 still stuck in 2997 04 270.Thirty minute delay to procedure.No ae to patient.'product discarded' has been selected for product status in this instance as there is no appropriate status available to represent the following local process: instrument will be sent to local engineering for assessment of wear and tear.If 'wear and tear' is assigned, a copy of the local assessment will be provided to the manufacturer for their record and case closure.In the case wear and tear cannot be assigned by the engineer, the product will be returned to the manufacturer as a 'product complaint' for investigation.

• Brand Name: EXPEDIUM VERSE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6967845
• Report Number: 1526439-2017-10885
• Device Sequence Number: 1850995
• Product Code: LXH
• UDI-Device Identifier: 10705034467450
• UDI-Public: (01)10705034467450
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 299704270
• Device Catalogue Number: 299704270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/22/2017
• 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