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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPLANT KIT 15X15; STAPLE, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPLANT KIT 15X15; STAPLE, FIXATION, BONE Back to Search Results
Model Number SE-1515TI
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2022
Event Type  malfunction  
Manufacturer Narrative
The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 january 7, 2022, the speedtitan compression implant kit on the inserter was unusable, directly out of the packaging.The plastic inserter deformed and continuous compression implant (cci) device was not able to fit in predrilled holes due to partially compressed.Another package item has the same defect.Procedure was completed successfully without any surgical delay.No patient consequence.This report is for one (1) speedtitan compression implant kit 15x15.This is report 1 of 2 for complaint (b)(4).
 
Manufacturer Narrative
The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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) 2022, the speedtitan compression implant kit on the inserter was unusable, directly out of the packaging.The plastic inserter deformed and continuous compression implant (cci) device was not able to fit in predrilled holes due to partially compressed.Another package item has the same defect.Procedure was completed successfully without any surgical delay.No patient consequence.This report is for one (1) speedtitan compression implant kit 15x15.This is report 1 of 2 for complaint (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.H10 additional narrative: d10: date of concomitant therapy is january 7, 2022.H3, h4, h6: part: se-1515ti, synthes lot: bse180072, supplier lot: n/a, release to warehouse date: january 26, 2018, expiration date: january 26, 2023, manufactured by: bme.No nonconformance reports (ncrs) were generated during production.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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the speedtitan compression implant kit 15x15 was cracked.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the speedtitan compression implant kit 15x15 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed: the current and manufactured revisions of drawings were reviewed.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.
 
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Brand Name
SPEEDTITAN COMPRESSION IMPLANT KIT 15X15
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)
SYNTHES BME : SAN ANTONIO
14785 omicron drive
#205
san antonio TX 78245
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13452742
MDR Text Key285154374
Report Number2939274-2022-00371
Device Sequence Number1
Product Code JDR
UDI-Device Identifier00810633021514
UDI-Public(01)00810633021514
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142292
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/26/2023
Device Model NumberSE-1515TI
Device Catalogue NumberSE-1515TI
Device Lot NumberBSE180072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2018
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM
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