MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER POLY SCREW 8X50MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186715850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.A review of the receiving inspection (ri) for viper poly screw 8x50mm ti was conducted identifying that lot number rl284994 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 22 apr 2020 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s).The image(s) was reviewed, and the complaint condition could be confirmed since the head of the screw has separated from the shaft.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 that on (b)(6) 2021 during an unknown surgery while placing a screw at the l4 vertebral body, the surgeon was turning the handle and encountered a higher insertion torque than normal.The screw head then disengaged from the screw shank and came off.It was advised that the surgeon tap the bone prior to screw placement, however he was simply replacing a screw that had been removed at that site previously and decided against tapping.No fragments were generated.Screw shank was removed using a different screwdriver.There was a surgical delay of ten (10) minutes.There were no patient consequences.The procedure was successfully completed.This report is for one (1) viper system polyaxial screw 5.5 x 8 x 50mm.This is report 1 of 2 for (b)(4).

• Brand Name: VIPER POLY SCREW 8X50MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11737277
• Report Number: 1526439-2021-00812
• Device Sequence Number: 19777655
• Product Code: NKB
• UDI-Device Identifier: 10705034122755
• UDI-Public: 10705034122755
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2021

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: 186715850
• Device Catalogue Number: 186715850
• Device Lot Number: RL284994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; UNKNOWN TORQUE DEVICES