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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown bolted 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: abou-khalil s, et al.(2020), results of open reduction internal fixation versus percutaneous iliosacral screw fixation for unstable pelvic ring injuries: retrospective study of 36 patients, european journal of orthopaedic surgery & traumatology, volum 30, pages 877¿884 (switzerland).The aim of the present study is to compare the clinical results of closed reduction and percutaneous fixation (crpf) or open reduction and internal fixation (orif) in surgical stabilization of posterior pelvic ring fractures.Between september 2007 and december 2017, 36 adult patients with unstable posterior pelvic ring injury who were treated with iliosacral fixation were included in the study.The patients were classified into 2 groups: the crpf group had 22 patients (median age 35.5 years, 4 females) stabilized under fluoroscopic or o-arm guidance and the orif group had 14 patients (median age 42.5 years, 2 females).In the crpf group, the patients underwent closed reduction performed by longitudinal traction and closed manipulation.The posterior lesions were fixed with an unknown synthes 7.3 mm cannulated cancellous screws while the anterior pelvic ring injuries were fixed with a competitor¿s plates.In the orif group, the posterior pelvic ring injuries were fixed with unknown synthes 3.5 mm reconstruction plates, unknown synthes 3.5 mm locking compression plates, unknown synthes bolted sacral bars, unknown synthes 7.3 mm cannulated cancellous screws, and 2 competitor¿s devices.The anterior pelvic ring injuries were fixed with a competitor¿s device.The median follow-up was 6 months for the crpf group and 10.5 months for the orif group.Complications were reported as follows: crpf group: 1 patient had a neuropathic pain in the territory of s1 and s3 due to malpositioning of the screws.After changing the screws, the patient fully recovered without sensory or motor loss.Orif group: 1 patient had an infection.This report is for the unknown synthes bolted sacral bars.This report captures the reported event of infection.A copy of the literature article is being submitted with this regulatory report.This is report 2 of 5 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H10 additional narrative: h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 - THREADED BARS
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12593934
• MDR Text Key: 278116254
• Report Number: 8030965-2021-08504
• Device Sequence Number: 1
• Product Code: JDW
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention