• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDARC COMPRESSION IMPL KIT 11X12X10; STAPLE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDARC COMPRESSION IMPL KIT 11X12X10; STAPLE, FIXATION, BONE Back to Search Results
Model Number SE-111210A
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on (b)(6) 2021, the speedarc compression inplant kit staple was discovered as not centered or straight on insertion handle.Product was not used or opened.No patient consequence reported.This report is for one (1) speedarc compression impl kit 11x12x10.This is report 2 of 2 for (b)(4).
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6 - codes updated to imdrf codes.Visual inspection: the complaint device speedarc compression impl kit 11x12x10 (product code: se-111210a, lot number: bse180997) was returned to cq west chester for investigation.During visual inspection, no issues were found on the device.Functional test: the implant was found not properly assembled on the inserter handle inside the packaging.Can the complaint be replicated with the returned device(s)? the complaint can be replicated as a functional test was not performed.Dimensional inspection: complaint relevant dimensions could not be measured from the device because of the design.Document/specification review: the manufactured revision of the item could not be retrieved, hence the most recent version of the drawing were reviewed.Conclusion: the implant was misaligned on the inserter.Hence, a functional test was not performed, and complaint could not be confirmed.Based on the investigation conducted, it has been determined that the most probable root cause for this type of complaint is the historical packaging design, with transit/handling being a contributing factor.Capa-007630 was opened to address the design remediation of all bme product lines.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - no ncr's generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPEEDARC COMPRESSION IMPL KIT 11X12X10
Type of Device
STAPLE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key12804580
MDR Text Key285355106
Report Number2939274-2021-06662
Device Sequence Number1
Product Code JDR
UDI-Device Identifier00810633021415
UDI-Public(01)00810633021415
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/06/2023
Device Model NumberSE-111210A
Device Catalogue NumberSE-111210A
Device Lot NumberBSE180997
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2021
Initial Date FDA Received11/12/2021
Supplement Dates Manufacturer Received12/09/2021
12/16/2021
Supplement Dates FDA Received12/10/2021
12/16/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/10/2018
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
SPEEDARC COMPRESSION IMPLANT KIT 11X12X10MM; UNK - NAIL INSERTION HANDLES
-
-