MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown matrixrib locking plate construct/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

This report is being filed after the review of the following journal article: zhou x, et al.(2021), application of 3d printing and framework internal fixation technology for high complex rib fractures, journal of cardiothoracic surgery, volume 16, number 5, pages 1-6 (china).This study aimed to explore the feasibility and clinical efficacy of pre-shaping locking plates based on 3d printed rib models, as well as the application of framework internal fixation techniques in minimally invasive surgery of high complex rib fractures.From june 2016 to august 2019, 16 patients who underwent surgical treatment of high complex rib fractures were included in the study.There were 12 males and 4 females with a mean age of 50 years (range, 26 to 27 years).The results of multi-slices spiral ct scan were processed.The 3d model fracture was reduced to its pre-injury form shaping the unknown synthes matrixrib locking plate according to the restored rib model, the placement position and the direction of the locking plate, the length and number of screws were recorded and the locking plate was then sterilized prior to use.During the procedure, the unknown synthes matrixrib locking plate was implanted according to the preoperative planning.After the surgery, all patients were given non-steroidal anti-inflammatory drugs (nsaids) for analgesia, and the pain level was evaluated according to the nrs at 10:00 a.M.Every day.Once the nrs score reaches 4 points or less, the analgesic drugs will be stopped.Follow-up were conducted complications were reported as follows: 2 patients had analgesics used again due to worsened chest pain after stopping the drug.1 stopped analgesic drugs 2 weeks after surgery, whereas another patient did not stop the analgesic drugs until 6 weeks after surgery.This report is for the unknown synthes matrixrib locking plate construct.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: MATRIXRIB PLATE/SCREWS
• Type of Device: PLATE, FIXATION, BONE
• 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: 12501999
• MDR Text Key: 272558356
• Report Number: 8030965-2021-07889
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• 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: 08/23/2021
• 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
• Patient Outcome(s): Required Intervention