MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SFX CROSS CONNECTOR SYSTEM CONNECTOR A5 5.5 X 41-49MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	189401405
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during a removal procedure (l4, l5) on (b)(6) 2022, the tip of the driver shaft broke off and got stuck to a setscrew of the cross link.The surgeon managed to remove the cross link.The surgeon commented that the setscrew on the cross link had been quite tight when they tried to loosen it with the driver shaft.Procedure was completed with less than thirty minutes delay.This report is for a expedium sfx cross connector system connector a5 5.5 x 41-49mm.This is report 2 of 2 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.Additional device product codes: kwq, osh, mni, mnh, kwp.A review of the receiving inspection (ri) for sfx,5.5,ti, med, size a5 was conducted identifying that lot number gm5597111 was released in one batch.Batch1: lot qty of (b)(4) units were released on 11 apr 2018 with no discrepancies.Supplier: (b)(4).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.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 sfx,5.5,ti, med, size a5 was found the inner section of screw stripped.This can be related with the unable to disassemble complaint.A dimensional inspection for the sfx,5.5,ti, med, size a5 was unable to be performed due to post manufactured damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A functional test was performed with a screwdriver of t20 and the screw is stuck in the mating device.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 a5 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 A5 5.5 X 41-49MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15692518
• Report Number: 1526439-2022-01892
• Device Sequence Number: 20523957
• Product Code: NKB
• UDI-Device Identifier: 10705034168128
• UDI-Public: (01)10705034168128
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 189401405
• Device Catalogue Number: 189401405
• Device Lot Number: OM9844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2018
• 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: SFX X20 TORQUE DRIVER SHAFT
• Patient Sex: Unknown