MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH ROD, 120MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179762120

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Device report from synthes reports an event in australia as follows: it was reported that the patient had surgery during which the screw was implanted on (b)(6) 2022.On (b)(6) 2022, the patient had a revision surgery because the two (2) 6 x 50mm screws were broken and there was a fracture between t11 & t12.The surgeon removed the whole construct to replace screws and extended the construct to t9.During manufacturer's investigation of the returned device it was identified that rod, 120mm was cut.This device condition was evaluated and determined to be reportable on november 18, 2022.This report is for one (1) rod, 120mm this is report 3 of 4 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.Additional device product codes: kwp;kwq;mnh;mni;osh.Reporter is a j&j sales representative.A product investigation was conducted.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 rod, 120mm was observed cut, the cut fragment was not received in the evidence provided.In addition, the surface also exhibits minor scratches.A dimensional inspection for the rod, 120mm 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 rod, 120mm 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.A device history record (dhr) review was conducted: product code: 179762120, lot number : bdo1ewh, a manufacturing record evaluation was performed for the finished device.Product code: 179762120, lot number: bdo1ewh, it was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 29/03/2021, qty: 149.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: ROD, 120MM
• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 8472871282
• MDR Report Key: 15924897
• MDR Text Key: 308072307
• Report Number: 1526439-2022-02078
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034077406
• UDI-Public: (01)10705034077406
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179762120
• Device Catalogue Number: 179762120
• Device Lot Number: BDO1EWH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female