MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; SCREW, FIXATION, BONE

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown locking screw/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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: sharma, g.M.Et al (2017), treatment of three-and four-part proximal humerus fractures by multiloc nailing technique- a prospective study.Journal of clinical and diagnostic research, volume 11, no.11, pages 9-11 (india) the aim of the prospective study was to study the functional and radiological outcome of patients with three-and four-part proximal humerus fractures treated with multiloc nailing system between december 2013 and february 2015.There were 21 patients (7 males and 14 females), who were above 60 years old, with three- and four-part proximal humerus fracture treated with synthes multiloc® proximal humerus nail.The proximal multiple locking was done using the 3.5mm and 4.5mm screw in screw.Ascending screws were then inserted followed by distal locking.Regular follow-up was done for all the patients at one, three, six, 12 and 24 months respectively.Complications were reported as follows: there was one case of varus collapse which showed malunion.There were no clinical symptoms and thus, no active intervention was done for the same.There were two cases of shoulder impingement in the present study.Constant score showed one case having fair functional outcome, and one case having poor functional outcome.There was one case in which there was articular surface intrusion of the screw, which was removed at a later date after six months.This report is for an unknown locking screw this is report 5 of 5 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7409630
• MDR Text Key: 104806313
• Report Number: 8030965-2018-52917
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• 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: 03/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention