MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 1.45MM NITINOL GUIDEWIRE BLUNT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286705320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Local Reaction (2035); No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
Tip of wire broke off while removing and a 2 cm fragment remained in the vertebral body of patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at the guidewire¿s distal tip.The second half of the tip was not returned for analysis as it remained in the vertebral body of patient.Device was then sent for fracture analysis.The fracture analysis suggests that the tip underwent a static overload failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the guidewire tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the tip underwent a static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.45MM NITINOL GUIDEWIRE BLUNT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7537284
• Report Number: 1526439-2018-50485
• Device Sequence Number: 16747383
• Product Code: LXH
• UDI-Device Identifier: 10705034507859
• UDI-Public: (01)10705034507859
• 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,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 286705320
• Device Catalogue Number: 286705320
• Device Lot Number: GM4732201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1