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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LOCKING SCREWDRIVER BODY; EXTREMITY INSTRUMENTS : SCREWDRIVERS

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DEPUY INTERNATIONAL LTD - 8010379 LOCKING SCREWDRIVER BODY; EXTREMITY INSTRUMENTS : SCREWDRIVERS Back to Search Results
Catalog Number 230792003
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2024
Event Type  malfunction  
Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Delta xtend screw drivers supplied in loan kit were broken.Could not be used as a tooth was missing.
 
Event Description
Additional information was received: all pieces were retrieved as the instrument was broken already.
 
Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - photographs/x-rays were provided but they do not represent the current complaint condition or a device malfunction, example; photos of tags, photos of sticker sheets (and the allegation is unrelated to labeling), unrelated photos, etc.According to the information received, "delta xtend screw drivers supplied in loan kit were broken.1 couldn't be used as a tooth was missing and the 2nd had a bent tooth that broke the screw." the product was not returned to depuy synthes, however photos were provided for review.See attachment a-10805511 source data pc -(b)(4).The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Corrected: d4 (expiration date) the expiration date ((b)(6) 2045) submitted in the previous medwatch was reported in error.The device involved was an instrument and does not have an expiration date.
 
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Brand Name
LOCKING SCREWDRIVER BODY
Type of Device
EXTREMITY INSTRUMENTS : SCREWDRIVERS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key18926205
MDR Text Key337926661
Report Number1818910-2024-06018
Device Sequence Number1
Product Code HXX
UDI-Device Identifier10603295116561
UDI-Public10603295116561
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/18/2024
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 Catalogue Number230792003
Device Lot Number5294421
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received03/18/2024
Supplement Dates Manufacturer Received03/16/2024
04/01/2024
Supplement Dates FDA Received03/21/2024
04/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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