MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: TRAUMA; SCREW,FIXATION,BONE

Device Problem Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 05/29/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screws: trauma/unknown lot.Part and lot numbers are unknown; udi 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: yu, c.Et al (2020), traditional three-dimensional printing technology versus three-dimensional printing mirror model technology in the treatment of isolated acetabular fractures: a retrospective analysis, journal of international medical research, vol.48 (5), pages 1¿12, https://doi.Org/10.1177/0300060520924250 (china).The aim of this retrospective study of prospectively gathered data is to compare the clinical outcomes of traditional 3d printing technology and 3d printing mirror model technology for the treatment of isolated acetabular fractures.Between june 2011 to december 2017, a total of 146 patients underwent treatment using traditional 3d printing technology (group t) or 3d printing mirror model technology (group m).Group t comprised 72 patients (32 male and 40 female) with a mean age of 71.34±8.15 years, and group m comprised 74 patients (30 male and 44 female) with a mean age of 71.65±7.76 years.Surgery was performed using a reconstruction plate (synthes inc., west chester, pa, usa).The patients were reviewed clinically and radiographically at 1, 3, 6, 9, and 12 months postoperatively and yearly thereafter.The mean follow-up duration was 29 months (range, 24¿34 months).The following complications were reported as follows: group t.32 patients had an imperfect fracture reduction quality.7 patients had a poor fracture reduction quality.12 patients had implant failure/revision.5 patients had refracture.3 patients had femoral fracture.5 patients had lower limb shortening (>1.5 cm).23 patients had heterotopic ossification (iii and iv).8 patients had infection.1 patient had symptoms of nerve stimulation.4 patients had traumatic osteoarthritis.21 patients had implant loosening.Group m.20 patients had an imperfect fracture reduction quality.4 patients had a poor fracture reduction quality.3 patients had implant failure/revision.4 patients had refracture.1 patient had femoral fracture.1 patient had lower limb shortening (>1.5 cm).7 patients had heterotopic ossification (iii and iv).6 patients had infection.1 patient had symptoms of nerve stimulation.2 patients had traumatic osteoarthritis.8 patients had implant loosening.This report is for an unknown synthes plate/screws constructs, unknown synthes reconstruction plates, and unknown synthes screws.This report is for one (1) unk - screws: trauma.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11102112
• MDR Text Key: 226231683
• Report Number: 8030965-2020-10077
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 12/04/2020
• 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