MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER MONO SCREW 6X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186717645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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
I received from the operating room manager the broken devices in a bag.No further information was received.Upon request it was confirmed that the procedures were successfully completed.The surgery date was derived from the steri sticker and might not be the actual date as it can take up to a day to complete cleaning and sterilisation.No further information is available at the moment.Was surgery delayed due to the reported event? yes.If yes, number of minutes: about 5min.Action taken when event occurred? screws replaced with new screws.Was procedure successfully completed? yes.Were fragments generated? unknown.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.This complaint involves three (3) device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The returned screw features minimal signs of use beyond some surface markings.However, the top threads of the tulip head are torn and damaged.Some of the material is missing entirely.The remaining portions are significantly damaged, loose, and would not be usable with a compatible set screw.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.The root cause of the damage to the threads of the pedicle screw cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading a set screw during insertion into the tulip head of this pedicle screw.This would place stress on the threads of the tulip head, potentially resulting in them becoming damaged as in this instance.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, 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: VIPER MONO SCREW 6X45MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9131242
• Report Number: 1526439-2019-52170
• Device Sequence Number: 2262520
• Product Code: NKB
• UDI-Device Identifier: 10705034123479
• UDI-Public: (01)10705034123479
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186717645
• Device Catalogue Number: 186717645
• Device Lot Number: RL210378
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1