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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SOLO PINNING SYSTEM; ATTUNE INSTRUMENTS : FIXATION PINS

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DEPUY IRELAND - 9616671 ATTUNE SOLO PINNING SYSTEM; ATTUNE INSTRUMENTS : FIXATION PINS Back to Search Results
Model Number 2544-00-111
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
There appears to be a hair or fibre contained within sterile packaging next to pins.
 
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 : examination of the returned device confirmed the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.
 
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Brand Name
ATTUNE SOLO PINNING SYSTEM
Type of Device
ATTUNE INSTRUMENTS : FIXATION PINS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10561312
MDR Text Key207783737
Report Number1818910-2020-20559
Device Sequence Number1
Product Code LXH
UDI-Device Identifier10603295129943
UDI-Public10603295129943
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup
Report Date 09/09/2020
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 Model Number2544-00-111
Device Catalogue Number254400111
Device Lot NumberJ7060A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Initial Date Manufacturer Received 09/09/2020
Initial Date FDA Received09/21/2020
Supplement Dates Manufacturer Received09/22/2020
10/02/2020
Supplement Dates FDA Received09/28/2020
10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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