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

Device Problem Migration (4003)

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown 6.0 mm non-cannulated sacral bars/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: wagner d., et al (2021): trans-sacral bar osteosynthesis provides low mortality and high mobility in patients with fragility fractures of the pelvis, scientific reports volume 11, pages 1-9 ((b)(6)).This retrospective study aims to analyze clinical outcomes regarding mobility, quality of life, and mortality of patients with fragility fractures of the pelvis (ffp) treated with trans-sacral bar (tb) osteosynthesis through s1.From 2005 to 2017, medical charts of adult patients with a pelvic fracture after low-energy trauma were reviewed.Low-energy fractures of the posterior pelvic ring were stabilized in 85 patients with trans-sacral bar (tb).Seventy-nine were females and six males.The median age was 78.0 years (iqr 73¿84, 50¿95; median for males 85, and females 77, p 0.358).During fixation a a 6.0 mm non-cannulated sacral bar (depuy synthes, oberdorf, switzerland) was used.Overall, median follow-up was 166.9 weeks.The following complications were reported as follows: twenty-nine patients were reported dead during complete follow-up (four died later than fu interview), the status of one was unknown.They died at a mean of 148.8 weeks after admission.Four hematomas required operative debridement (one with additional interventional coiling).One infected hematoma was debrided.One peri-implant infection with an epidural abscess was debrided.1 tb was removed due to pain (due to non-specific pelvic pain).1 tb was removed due to pain (pain in s1 dermatome due to malpositioning).One malpositioned tb was removed and changed to a transiliac internal fixator.Four patients had revision for a loosened tb (all without additional is screws and all with delayed presentation, two with persisting anterior instability and one with non-union of the sacral fracture); two of these patients developed peri-implant infection after the revision operation needing operative debridement.This report is for an unknown synthes 6.0 mm non-cannulated sacral bar.This report captures the reported events of four patients had revision for a loosened tb (all without additional is screws and all with delayed presentation, two with persisting anterior instability and one with non-union of the sacral fracture); two of these patients developed peri-implant infection after the revision operation needing operative debridement.This is report 2 of 2 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - THREADED BARS
• 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: 13759790
• MDR Text Key: 291713711
• Report Number: 8030965-2022-01604
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2022
• 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