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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BONE STAPLE: SPEEDTITAN; STAPLE, FIXATION, BONE

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SYNTHES GMBH UNK - BONE STAPLE: SPEEDTITAN; STAPLE, FIXATION, BONE Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Muscular Rigidity (1968); Pain (1994); Non-union Bone Fracture (2369)
Event Date 01/01/2021
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.D1, d2, d3, d4, g4-510k: this report is for an unknown bone staple: speedtitan/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: mcknight, r.R.Et al (2021), retrospective comparison of capitolunate arthrodesis using headless compression screws versus nitinol memory staples for slac and snac wrist: radiographic, functional, and patient-reported outcomes, hand xx.Xx., pages 1-9 (usa).The purpose of this study was to compare the clinical outcomes of cla for snac or slac wrist treatment using either compression screws or nitinol staples between (b)(6) 2009 and (b)(6) 2017, a total of 40 patients with a mean age of 49 years who had scaphoid nonunion advanced collapse (snac) and scapholunate advanced collapse (slac) wrist were included in this retrospective study.The patients were divided into two groups depending on the fixation type used; group 1 (cla with staples; speedtitan, synthes) with 31 patients and a mean follow up of 14 months; group 2 (cla with screws; synthes, headless compression screws, and acumed) with 9 patients and a mean follow up of 47 months.The following complications were reported as follows: - 4 patients who showed nonunion on ct, 3 were done within 3 months of surgery (3 months, 2 months, 2 weeks) and the fourth at 3 years postoperatively due to continued pain.Group 1 (staples group) - 2 patients with hardware complications; 1 patient experienced loosening of the staple resulting to revision fusion which went onto a fibrous nonunion, the second patient experienced dorsal impingement with stiffness that resulted in a reoperation of staple removal and capsulotomy after radiographic union was achieved.Group 2 (screw group) - 2 patients with hardware complications (screw backout into the radiocarpal and midcarpal joints); 1 patient went onto radiographic union after screw removal leaving second screw in place, and the other patient underwent screw exchange and eventually went onto nonunion.- 2 patients had posterior interosseous nerve neurectomy - 1 patient with ct at 2 weeks had screw backout and went onto revision surgery and eventual union.This report is for an unknown synthes speedtitan.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).
 
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Brand Name
UNK - BONE STAPLE: SPEEDTITAN
Type of Device
STAPLE, 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 Key18533640
MDR Text Key333095775
Report Number8030965-2024-00997
Device Sequence Number1
Product Code JDR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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