MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A4 5.5 X 37-41MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189401404
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in south korea as follows: it was reported on august 19, 2022 that the center setscrew of this implant was not tightened when distributor opened its package for inventory entrance inspection.It seemed to be in the wrong position.When the distributor loosened the set screw, they found this thread to be worn out.This report involves one expedium sfx cross connector system connector a4 5.5 x 37-41mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional product codes: osh, mni, kwp, kwq, mnh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part # 189401404 lot # om11720 supplier: (b)(4) batch1: lot qty of (b)(4) unit were released on 02 mar 2022with no discrepancies.Batch2: lot qty of (b)(4) unit were released on 17 jan 2022 with no discrepancies.No ncrs were generated during production.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the head and threads of one of the set screw for sfx,5.5,ti, med, size a4 was observed stripped.The rest of the surface of the device shows normal wear which would not contribute to the complaint condition.A dimensional inspection for the sfx,5.5,ti, med, size a4 was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the sfx,5.5,ti, med, size a4 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.

• Brand Name: EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A4 5.5 X 37-41MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15410959
• Report Number: 1526439-2022-01579
• Device Sequence Number: 14926308
• Product Code: NKB
• UDI-Device Identifier: 10705034168111
• UDI-Public: 10705034168111
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 189401404
• Device Catalogue Number: 189401404
• Device Lot Number: OM11720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS
• Patient Sex: Unknown