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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

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DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE Back to Search Results
Model Number 222983
Device Problem Break (1069)
Patient Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative
Udi: (b)(4).The lot number was unknown.Investigation summary: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Event Description
It was reported by the customer in (b)(6) that during a revision procedure performed on (b)(6) 2021 to an initial procedure of biceps tendon repair performed on (b)(6) 2021, the surgeon observed that there was a rupture on the thread flushed with the anchor on the gii qa+ o/c cp-2 device; and hence, there was final abandonment of the anchor; and that it remained in place in the bone.Therefore, the surgeon put a new anchor next to the old one using the same hole in the cortical bone.It was reported that upon tightening the two threads, one broke again in the anchor.The current status of the patient post-surgery was unknown.No additional information was provided.
 
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Type of Device
SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12439341
MDR Text Key270309348
Report Number1221934-2021-02652
Device Sequence Number1
Product Code JDR
UDI-Device Identifier10886705008612
UDI-Public10886705008612
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K051989
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number222983
Device Catalogue Number222983
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/24/2021
Initial Date FDA Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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