MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONF INTRO NDLE, DIA, 11G 6"; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	283903611
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	09/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the reported devise was used to iliac to create the bone hole for the invasive osteosynthesis on (b)(6) 2018.During the surgery, the surgeon felt difficulty to remove the cannula from the patient¿s bone hole when the surgeon removed the cannula after passed the guide wire.The surgeon used the hummer to remove the cannula, but the surgeon could not remove.Then, the surgeon used the pliers, however, the cannula was broken and remained in the patient¿s bone.The surgeon decided to keep the broken fragment into the patient¿s body, and will be removed from the patient¿s body during the scheduled surgery (2 or 3 month later, surgery date is not fixed yet).Here was 60 min.Surgical delay.No further information was provided by the hospital.

• Brand Name: CONF INTRO NDLE, DIA, 11G 6"
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7935027
• Report Number: 1526439-2018-50950
• Device Sequence Number: 940740
• Product Code: GAA
• UDI-Device Identifier: 10705034209494
• UDI-Public: (01)10705034209494
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 283903611
• Device Lot Number: 113593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR