MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	189401406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot - a review of the receiving inspection (ri) for sfx,5.5,ti, med, size a6 was conducted identifying that lot number om11195 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 13 oct 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review - the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 this was a plif (l4-s) for treating spondylolisthesis.The cross connector broke off during bending.Procedure was completed without surgical delay.This report is for one (1) expedium sfx cross connector system connector a6 5.5 x 49-66mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A6 5.5 X 49-66MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12572665
• Report Number: 1526439-2021-02102
• Device Sequence Number: 11770183
• Product Code: KWQ
• UDI-Device Identifier: 10705034168135
• UDI-Public: (01)10705034168135
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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 Model Number: 189401406
• Device Catalogue Number: 189401406
• Device Lot Number: OM11195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1