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 Pneumothorax (2012)

Event Type  Injury  

Event Description

Device report from synthes reports an event in switzerland as follows: this report is being filed after the review of the following journal article: minervini f., et al (2021) nonunion of traumatic rib fractures: a suitable indication for surgery?, european journal of trauma and emergency surgery xxxx, pages 1-5 (switzerland) this retrospective cohort study aims to present a retrospective cohort analysis of patients who underwent surgical stabilization of rib fractures (ssrf) following nonunion of rib fractures.Between january 2010 and march 2021 , all patients over 18 years old who underwent ssrf for symptomatic post-traumatic pseudoarthrosis of rib fractures a level 1 trauma center in switzerland were identified.In the examinated study period, 1146 patients were assessed for thoracic trauma with rib fractures, and of those, 492 underwent surgical stabilization.A total of 19 patients with symptomatic nonunion following traumatic rib fractures who underwent surgical stabilization with locking plates were identified and ultimately included in this study.17 patients were men and median age was 49 years (range 25¿69 years).Osteosynthesis was performed using locking compression plates and bicortical screws (synthes matrixrib, johnson and johnson, usa).Median follow-up was 46.94 months (range 0¿103).The following complications were reported as follows: (pt.No 3) age at surgery was 62-year-old had pneumothorax also requiring a chest tube.(pt.No 9) age at surgery was 62-year-old had pleural effusion requiring a chest tube.After a median follow-up of 46.94 months (range 0¿103), was still suffering from pain after surgery.(pt no.2)age at surgery was 42-year-old underwent osteosynthesis material removal (grade iiib complication) due intractable persistent pain.(pt.No 6) age at surgery was 52-year-old, after a median follow-up of 46.94 months (range 0¿103), was still suffering from pain after surgery.(pt.No 11) age at surgery was 60-year-old,, after a median follow-up of 46.94 months (range 0¿103), was still suffering from pain after surgery.This report is for unknown synthes matrixrib.This is report 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown constructs: matrixrib plate/screws/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.

• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14829761
• MDR Text Key: 295058531
• Report Number: 8030965-2022-04352
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• 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: 06/13/2022
• 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