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

Device Problems Break (1069); Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown dynamic hip screw (dhs)/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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: jones d., (1986) trochanteric fractures of the femur,a randomised prospective trial comparing the jewett nail-plate with the dynamic hip screw the journal of bone and joint surgery vol.68- b.No.4, pages 1-4 (united kingdom).This study aims to assess the results in two groups of elderly women with trochanteric fractures treated either by a jewett nailplate (jnp) or by a dhs.Between november 1981 and february 1983, a total of 98 patients women more than 60 years old (average 8 1.7 years) were included in the study.Random allocation resulted in 51 patients being in the dhs group and 47 in the jnp group.At clinical review after six weeks, three months and six months, pain and mobility were evaluated.The following complications were reported as follows: 9 patients died during the study period.Operative difficulties occurred more frequently when a dhs was used (10 patients).96 patients had no compression postoperatively.50 patients had no compression 6 weeks postoperatively.44 patients had no compression 3 months postoperatively.53 patients had no compression 6 months postoperatively.8 patients had loss of fixation and or penetration of the device into the hip 6 weeks postoperatively.17 patients had loss of fixation and or penetration of the device into the hip 3 months postoperatively.Technical complications at the time of fixing the device occurred significantly more often with the dhs.One complication with the dhs was comminution of bone at the site of reaming; this required a hubbard nail-plate, a 95) blade-plate, on a dhs of 140 or 150.8 patients had loss of fixation and or penetration of the device into the hip 6 weeks postoperatively.17 patients had loss of fixation and or penetration of the device into the hip 3 months postoperatively.A dynamic hip screw in place.The original fracture.Figure 4 immediately after operation.Figure 5 seven months later: note how the screw has slid along its barrel.Other complications included failure of the screw to grip the head in one case, and a split in the lateral cortex in another other complications included failure of the screw to grip the head in one case, and a split in the lateral cortex in another.This is report 5 of 5 for (b)(4).This report is for an unknown synthes dynamic hip screw (dhs).

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10212255
• MDR Text Key: 201243076
• Report Number: 8030965-2020-04549
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• 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: 06/26/2020
• 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