MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 199721001S

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Additional procodes: kwp, kwq, mnh, mni, osh.Initial reporter: synthes employee.The investigation could not be completed, no product was received; 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020 that the patient was underwent of psf (posterior spinal fusion) surgery for treating the pelvic fracture.After placing a rod, the surgeon tried to tighten setscrews.But all the setscrews were cross threaded.The setscrews were removed and found that some threaded segments had come off.The procedure was delayed by 90 minutes.Concomitant device reported: unknown rod (part#: unknown, lot#: unknown, quantity: 1).Unknown screwdriver (part#: unknown, lot#: unknown, quantity: 1).This is report 4 of 6 for (b)(4).

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.The complaint device was not received for investigation.The following investigation is based on the image provided in the attachment.The image was reviewed, and the complaint condition could be confirmed because screw threads were stripped and peeled off as seen in the attached image.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history: the dhr of product code 199721001s, lot wg1211, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on october 28, 2019.Qty.288.The dhr was electronically reviewed.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 Description

Updated: the surgeon confirmed that no fragment had been left in the patient's body through intraoperative imaging and postoperative x-ray.

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.B5: updated information.D10: complainant part is not expected to be returned for manufacturer review/investigation.H11: corrected data.E1: corrected reporter information.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 Description

Updated: the patient outcome was stable.

• Brand Name: 5.5 EXP VERSE UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9612529
• MDR Text Key: 176673539
• Report Number: 1526439-2020-00413
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466149
• UDI-Public: (01)10705034466149
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 199721001S
• Device Lot Number: WG1211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; UNKNOWN SCREWDRIVERS