MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR F9 5.5 X 36MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	189401209
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: mnh, kwq, kwp, mni and osh.Reporter is a synthes employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, during a spinal fusion for the treatment of a vertebral fracture the cross connectors screw stripped during final tightening.Another screw was used to complete the procedure.There was a less than thirty (30) minute surgical delay.This report involves one (1) expedium sfx cross connector system connector f9 5.5 x 36mm.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.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that sfx,5.5,ti, med, size f9 screws were stripped inside the hex.There were few scratches on the device and there is slight discoloration on the device.The dimensional inspection was not performed due to the post-manufacturing damage.The observed condition of the sfx,5.5,ti, med, size f9 in 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 stripped condition of the sfx,5.5,ti, med, size f9.While no definitive root cause could be determined, it is probable that the sfx,5.5,ti, med, size f9 was stripped due to the unintended.There was no indication that a design or manufacturing issue contributed to the complaint.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.H3, h6: a device history record (dhr) review was conducted: a review of the receiving inspection (ri) for sfx,5.5,ti, med, size f9 was conducted identifying that lot number om10269 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 08 feb 2019 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 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 F9 5.5 X 36MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11785758
• Report Number: 1526439-2021-00916
• Device Sequence Number: 14364080
• Product Code: NKB
• UDI-Device Identifier: 10705034167879
• UDI-Public: (01)10705034167879
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: 189401209
• Device Catalogue Number: 189401209
• Device Lot Number: OM10269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/25/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN TIGHTENER