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

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Perforation (2001); Urinary Tract Infection (2120); Unspecified Gastrointestinal Problem (4491)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for unknown screws/unknown lot.Part and lot number 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: tan, w.L.Et al (2020), bipolar hemiarthroplasty should not be selected as the primary option for intertrochanteric fractures in elderly patients aged 85 years or more, medicine, vol.99 (37), pages 1-5 (china).The aim of this retrospective study is to compare the early outcome of bph and pfna in elderly patients aged 85 years or more presented with itfs and understand whether bph should be selected as the first option for elderly itfs.Between january 1, 2017 to july 31, 2018, a total of 120 patients were included in the study.Patients enrolled in this study were grouped as follows: group a: patients treated with pfna; group b: patients treated with bph.Group a consists of 84 patients (24 male and 60 female) with a mean age of 88.73±3.13 years.Group b consists of 36 patients (12 male and 24 female) with a mean age of 89.33±3.69 years.Patients were followed up at 6 weeks, 3 months, half and year, 1 year, and annually thereafter for clinical and radiological examinations.The mean follow-up duration for group a and b was 20.10±8.00 and 17.93±8.73 months, respectively.The following complications were reported: group a: 12 patients (14.12%) had complications at 2 weeks after operation.5 patients had pulmonary infection.1 patient had urinary infection.5 patients had gastrointestinal dysfunction.1 patient had cut through of screws.The mortality rate was 13.10% within 12 months after operation.This report is for unknown synthes screws.This is report 1 of 1 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: 11404450
• MDR Text Key: 240027095
• Report Number: 8030965-2021-01553
• 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,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• 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: 02/08/2021
• 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