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Catalog Number 03.010.041
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Product development investigation was completed. The report indicates that the: customer quality (cq) engineering investigation: this complaint is confirmed for both returned devices. Visual inspection of the awl at cq revealed an oblique fracture of the distal tip occurred and the tip fragment was not returned. The material at the fracture site appears homogeneous when viewed under 5x magnification. Visual inspection of the insertion handle at cq revealed damage to the hole which accepts drill sleeves and therefore this complaint is confirmed. The inferior side of the hole shows significant post manufacturing damage (burrs, rolled over edges encroaching into the inside diameter). The entire device shows wear commensurate with over 11 years of field use and also post manufacturing damage. The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr. A relevant functional test could not be performed at cq as the drill sleeves involved in this intraoperative event were not returned to cq. Whether this complaint can be replicated at customer quality (cq) is not applicable for the broken awl. The complaint condition for the insertion handle was not able to be replicated at cq as the drill sleeves were not returned, however it was replicated using best fit gauge pins. No new malfunctions were identified as a result of the investigation. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Manufacturer Narrative
Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Dhr review was completed. Manufacturing location: (b)(4). Manufacturing date: 19. Sep. 2008. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event Description
It was reported that a patient underwent a femoral nailing due to a football injury. Upon opening the patient's proximal femur, it was noted that he had extremely hard bone so the surgeon used a 14. 0 mm cannulated awl after the opening reamer wouldn't advance. After sinking the 14. 0 mm cannulated awl it was noted that a piece of the awl broke off in the bone. The surgeon decided not to retrieve the piece and the surgery wasn't delayed. Then, when locking the nail proximally, the drill sleeves didn't pass through the handle easily, and they were difficult to remove. There wasn't a considerable delay due to this, but the surgeon mentioned how difficult it was to pass the sleeves. Concomitant device reported: drill sleeves, unknown nail. This report is for one (1) 14. 0 mm cannulated awl. This is report 1 of 2 for (b)(4).
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Type of DeviceAWL
Manufacturer (Section D)
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer (Section G)
im bifang 6
hagendorf CH461 4
SZ CH4614
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
MDR Report Key6901821
MDR Text Key256710353
Report Number3003875359-2017-10480
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03.010.041
Device Lot Number1989312
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/28/2017 Patient Sequence Number: 1