MAUDE Adverse Event Report: SYNTHES GMBH UNK - WASHERS; PIN, FIXATION, THREADED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown sacral washers/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.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 that on an unknown date the patient underwent an unknown procedure for a fixation of unilateral sacral fracture utilizing a dps sacral bar implant 260 mm with nuts and washers (stainless steel).Postoperatively, the patient presented an infection.Reoperation was due to infection.There was a known healing of fracture reported.Patient outcome is unknown.No further information is available.This report is for unknown sacral washers.This is report 4 of 4 for complaint (b)(4).

• Brand Name: UNK - WASHERS
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12562184
• MDR Text Key: 274281087
• Report Number: 8030965-2021-08237
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• 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
• Treatment: THREADED SACRAL BAR L260 Ø6 SST; UNK - NUTS; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR