MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CH SI POLYAXL SCREW 6 X 50MM; BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE

Model Number	179712650
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device history lot: a manufacturing record evaluation was performed for product code: 179712650 on lot number: 328244; and no non-conformances / manufacturing irregularities were identified during the manufacturing process.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 or Problem Description
It was reported by the sales rep that during an unknown surgery on an unknown date, it was observed that the expedium screw would not accept a set screw without stripping.According to the report, the surgeon removed a screw and put a new one in and upon checking they just look like a thread that was protruding out.It was further reported that the little protruding prohibited the set screw from screwing into the screw head.Another like device was used to complete the procedure with a delay of two minutes.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) si polyaxl screw 6 x 50mm device.This complaint involves one (1) device.

• Brand Name: SI POLYAXL SCREW 6 X 50MM
• Common Device Name: BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM, NON-STERILE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 14269314
• Report Number: 1526439-2022-00651
• Device Sequence Number: 19943305
• Product Code: MNH
• UDI-Device Identifier: 10705034067742
• UDI-Public: 10705034067742
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 179712650
• Device Catalogue Number: 179712650
• Device Lot Number: 328244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown