MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: CMF; SCREW,FIXATION,BONE

Device Problem Migration (4003)

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws: cmf/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patent experienced a post op cyst.The resection was going through the cyst.The screws, one (1) through three (3) did not line up with the plate.Hole four (4) was lost due to additional resection needed to clear the cyst margin.The occlusion was off and the patient needed to be placed into imf.This report involves one (1) unknown screws: cmf.This is report 4 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.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

No changes were made to the posterior osteotomy.The guides and resection were used and performed per the instructions.The planned resection and reading of the anatomy was correct, however the additional resection was not necessary.The only follow up required is to understand how the anterior screws did not line up with the plate and to ascertain how the patients bite became ¿off¿.The patient is doing incredibly well post-surgery.

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11783645
• MDR Text Key: 249299633
• Report Number: 8030965-2021-03612
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: CMF.; UNK - SCREWS: CMF.; UNK - PLATES: CMF; UNK - SCREWS: CMF
• Patient Outcome(s): Required Intervention