MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: 7.3 MM CANNULATED; SCREW, FIXATION, BONE

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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.Additional narrative: pma/510k: this report is for an unknown 7.3mm cannulated screw/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: gross, a.Et.Al.(2022).The surgical management of highly unstable fragility fractures of the sacrum with spinopelvic dissociation: a case series and proposal of a surgical treatment algorithm., injury , vol.53 (xx) pages 3377-3383., (switzerland).The aim of this retrospective review is to achieve sufficient fracture stability for immediate full weight bearing with as little surgical burden for this rather frail patient group as possible.Between january 2017 and december 2020, a total of 23 patients (18 females and 5 males with mean age of 84 years [range 67-93 years]) with ffp ivb were included in this study.Surgery was indicated in all patients with this fracture pattern with or without fracture displacement.Only full-threaded cannulated 7.3 screws (depuy synthes, ober- dorf, switzerland) with washers were used for ti-tss and iss.All screws were placed proximal to the horizontal fracture component.For lpf, four pedicle screws were bilaterally connected with ilium screws.This fixation device (viper 2 or prime depuy synthes, oberdorf, switzerland) was also inserted in a minimally invasive manner.In 15 patients, the diagnosis of ffp ivb was made upon the first presentation, eight patients presented with a documented fracture progression after an initially unilateral sacral fracture with or without involvement of the anterior pelvic ring.Median time between trauma and surgery was 19 days (range 10-60) in the group with the initial diagnosis of ffp ivb and 60 days (range 19-120) in patients with documented fracture progression.The following complications were reported as follows: 83 year old woman revealed fracture progression follow-up ct 10 weeks later due to immobilizing pain.Two patients had to be treated for postoperative mixed delirium.Revision surgery due to local seroma was performed in an- other patient after ti-tss in s1 and s2 18 days after the initial surgery.Three cases with screw loosening (13 %) (two ti-ts in s1 und one ti-ts in s2) were detected at six-week follow-up.One s1 ti-tss screw was removed because of soft tissue irritation, the other patients were free of symptoms.Thus, the hardware was left in place.No other hardware removal was performed.One patient had to undergo surgery for symptomatic lumbar spinal stenosis unrelated to the pelvic fracture four months after surgical stabilization.Three patients (14%) died within three months after surgery due to causes unrelated to their pelvic fracture or surgery.This article does not specify which of the depuy spine devices (viper 2 or prime) is associated with the adverse event for the fixation device.This report is for unknown cannulated 7.3 screws (depuy spine).This report captures the reported event of three cases with screw loosening (13 %) (two ti-ts in s1 und one ti-ts in s2) were detected at six-week follow-up.A copy of the literature article is being submitted with this medwatch.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - SCREWS: 7.3 MM CANNULATED
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16356755
• MDR Text Key: 309400138
• Report Number: 8030965-2023-01698
• Device Sequence Number: 1
• Product Code: HWC
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• 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: 01/31/2023
• 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