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Model Number 921B
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/28/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record for the reported finished good lot and components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection process. The actual device was discarded by the end user. No sterile devices from the finished good lot were returned for analysis. A retained sample from the device history record was available, visually reviewed and tested. No visual defects or abnormalities were observed. The device met all specifications including the usp tensile strength and bend/ductility requirements. The suture breaking during use most likely resulted from the interaction of specific procedural related stress in contrast to the suture strength. It's also possible the devices are being gripped on or near the swaged end of the needle, damaging the suture, allowing the suture to break free from the needle component. The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure. The ¿precautions¿ section in the ifu for the device states, ¿care should be taken to avoid damage when handling. Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps. To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point¿. Without receiving photos or the actual device for review or receiving additional details regarding the preoperative preparation of the device, tools utilized to grasp the needle device, procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event Description
Customer used sutures for tenotomy surgery and had two complications with them. First they kept ripping and second, the needle broke off in the patient. The patient had to be sent for xrays to confirm and patient had to go to an orthopedic surgeon to have it removed. The needle was removed without injury or complications.
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Brand NameLOOK
Type of DeviceLOOK¿ NYLON, 4-0, BLACK, 18", C17
Manufacturer (Section D)
corredor tijuana rosarito 2000
#24702-b ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
luis knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key12301288
MDR Text Key267522966
Report Number3010692967-2021-00029
Device Sequence Number1
Product Code GAB
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/14/2021,08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number921B
Device Lot NumberAAHF342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/28/2021
Device Age18 MO
Event Location Hospital
Date Report to Manufacturer07/14/2021
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2021 Patient Sequence Number: 1