MAUDE Adverse Event Report: CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC 4.0MM CANNULATED SCREW LONG THREAD/50MM; SCREW, FIXATION, BONE

Catalog Number	207.750.EM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the plant for investigation.The device history records (2) for lot 135471 were reviewed and no anomalies were uncovered. parts fell within specification limits and were deemed conforming. the sample was received and forwarded for evaluation.Once that investigation is completed, a follow up report will be filed.A capa has been initiated.
Event or Problem Description
Procedure was an orif, right elbow, medial epicondyle being done under general anesthesia.The physician implanted a cannulated screw (long thread) by hand.After the screw was in the patient, an x-ray was done and it was noticed that the distal tip of the screw had broken off.Physician took the screw out, and left the broken screw tip in.The physician then requested another cannulated screw and also advanced this screw by hand.Upon x-ray, he noticed that this screw had broken in half, was unwound from the core diameter of the screw, and also had the distal tip of the screw break off.The case was posted for 90 minutes, but actual or time was 121 minutes.Physician will continue to follow up with the patient, and will repeat the x-ray.
Additional Manufacturer Narrative
The sample was received and evaluated. outside lab testing confirmed that we are not able to reproduce the failure mode and the product was found to be conforming.Therefore, we were unable to determine the root cause of this occurrence.We will continue to monitor complaints for any trends.

• Brand Name: 4.0MM CANNULATED SCREW LONG THREAD/50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): CARDINAL HEALTH 247, INC F/K/A EMERGE MEDICAL, INC; 720 s colorado blvd ste 550s; denver CO 80246
• MDR Report Key: 5946968
• Report Number: 1423537-2016-00042
• Device Sequence Number: 705139
• Product Code: HWC
• UDI-Device Identifier: 00886020011192
• UDI-Public: 00886020011192
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2016

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
• Operator of Device: Physician
• Device Catalogue Number: 207.750.EM
• Device Lot Number: 135471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 09/27/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Weight: 55