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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); Non-union Bone Fracture (2369)

Event Date 06/02/2022

Event Type  Injury  

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.Additional narrative: 510k: this report is for an unk - screws: locking.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.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

Device report from synthes reports an event in turkey as follows: this report is being filed after the review of the following journal article: karagoz b., erdem m., cukurlu m., agir i., (2022) comparison of three different surgical treatment methods in humeral shaft fractures, pan african medical journal.Volume 42(88), pages 1-13 (turkey).This retrospective study aims to compare the radiological and clinical results of fixation procedures with single 4.5 mm locking compression plate (lcp), dual 3.5 mm lcp and imn used in the treatment of humeral shaft fractures.Between january 2016 and december 2020, patients who underwent surgery for humeral shaft fracture were determined by examining the hospital database.In the examinations, 102 patients who were operated on for humeral shaft fractures were detected.77 patients were included in the study.36 patients were female, 41 were male, and the mean age was 46.38±18.91 (18- 74 years) years.The patients were divided into three groups according to the surgical procedures: group a consisted of 31 patients (14 females and 17 males), age 44.61±19.10 years, who underwent single 4.5 mm lcp, group b consisted of 20 patients (8 females and 12 males), age 47.55±17.97 years, who underwent dual 3.5 mm lcp, and group c consisted of 26 patients ( 14 females and 12 males) , age 47.58±19.95 years, who underwent imn.The mean follow-up period was 36.67 months (12-60 months).Reported complications: group a (single 4.5 mm lcp): 8 nonunion.3 radial nerve palsy.3 shoulder rom restriction.5 elbow rom restriction.4 implant failure.Group b (dual 3.5 mm lcp): 1 radial nerve palsy.1 shoulder rom restriction.2 elbow rom restriction.1 implant failure.This report is for unknown synthes 4.5 mm lcp and unknown synthes 3.5 mm lcp.This is report 3 of 7 for complaint: (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16079399
• MDR Text Key: 306447570
• Report Number: 8030965-2022-11707
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2022
• 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