MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 6MM DOUBLE-LEAD TAP, CAN; TAP, BONE

Model Number	299704960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Revision procedure to restore lordosis.Dr.(b)(6), (b)(6) hospital, (b)(6) 2018.Instrument issue occurred during a revision surgery.The patient had very sclerotic bone.A portion of the instrument broke off and was not able to be retrieved.It remains deep in the ilium.The surgeon is not concerned and does not feel that the fragment will migrate.The remaining portion of the instrument is available for return.No x-ray images are available.(b)(4).

• Brand Name: 6MM DOUBLE-LEAD TAP, CAN
• Common Device Name: TAP, BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7713349
• Report Number: 1526439-2018-50704
• Device Sequence Number: 11042919
• Product Code: HWX
• UDI-Device Identifier: 10705034467023
• UDI-Public: (01)10705034467023
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2018

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: Health Professional
• Device Model Number: 299704960
• Device Catalogue Number: 299704960
• Device Lot Number: PU97391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1