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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ5 12MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

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DEPUY IRELAND - 9616671 ATTUNE CONV SHIM SZ5 12MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Catalog Number 254500929
Device Problems Break (1069); Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2023
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
It was reported that the size 5 size 6 12mm shim cracked and one piece broke off.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary it was reported that the size 5 size 6 12mm shim cracked and one piece broke off.The device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned sample revealed that the attune conv shim sz5 12mm was found broken from the left shim.The broken fragment was returned for examination.Also it was observed cracked from the right shim near to the metal bushing.Therefore the reported condition can be confirmed.The thermal properties of the metal bushing and radel trial body are different resulting in the material to expand and contract at different rates.This puts a significant amount of stress on interfacing materials.Radel, being highly brittle, will succumb to these thermal stresses in the form of stress cracking.This cracking can be accelerated by high frequency autoclave cycles and/or the use of harsh chemicals, however, it is recognized these outside contributing factors act as a catalyst to the propagation of the cracks which ultimately can lead to catastrophic failure of the shims.Due to crack propagation being recognized as an inherent risk of the shims after repeated use, the potential cause is traced to end of life.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was performed not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune conv shim sz5 12mm would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.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.H10 additional narrative:.
 
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.
 
Event Description
Additional information received from sales rep: a.Was there a surgical delay because of this event? if yes, what is the duration of the delay? -no.B.Was there any adverse consequences that affected the patient because of the reported event? -no.
 
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Brand Name
ATTUNE CONV SHIM SZ5 12MM
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
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 Key18282033
MDR Text Key329896308
Report Number1818910-2023-24813
Device Sequence Number1
Product Code HWT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/07/2023
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 Number254500929
Device Lot NumberBFA13D7
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/30/2023
Initial Date FDA Received12/07/2023
Supplement Dates Manufacturer Received12/13/2023
12/28/2023
Supplement Dates FDA Received12/16/2023
12/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2015
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 Age65 YR
Patient SexMale
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