MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179712640

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/03/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during an unknown procedure, the screws were broken.No further information provided.This report is for one (1) si polyaxl screw 6 x 40mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: initial reporter is synthes sales representative (b)(4).The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment (img-20220310-wa0007.Jpg).Visual analysis of the photo revealed that the si polyaxl screw 6 x 40mm fractured at the shaft.No other issues were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for si polyaxl screw 6 x 40mm.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 history lot: a device history record (mre) review, was not possible because the required lot code was not provided.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: SI POLYAXL SCREW 6 X 40MM
• 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 (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: 14053145
• MDR Text Key: 288874402
• Report Number: 1526439-2022-00545
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034067728
• UDI-Public: 10705034067728
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179712640
• Device Catalogue Number: 179712640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention