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

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).

• 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 Key: 18533640
• MDR Text Key: 333095775
• Report Number: 8030965-2024-00997
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention