MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 T20 HEXLOBE DRIVER SHAF

Model Number	286725020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: mnh, mni, kwq, kwp.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a posterior percutaneous fusion (l5) treating spinal canal stenosis surgery.During the surgery, the surgeon tried to insert the xtab screw (unk) to the hardened bone.As it became difficult to continue the insertion, he decided to remove the screw.While the driver shaft was in use for screw removal, the tip of the driver shaft broke.The fragment was removed from the patient¿s body.The procedure was completed less than 30-minute surgical delay.No further information is available.This complaint involves two (2) devices.This report is for (1) viper2 t20 hexlobe driver shaf.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (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.H10 additional narrative: h3, h6: investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that viper2 t20 hexlobe driver shaf the tip of the driver shaft only the tip was returned the whole device was not received and no other issues were identified.The dimensional inspection was not performed due to past manufacturing damage.The observed condition viper2 t20 hexlobe driver shaf in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the viper2 t20 hexlobe driver shaf.While no definitive root cause could be determined, it is probable that the viper2 t20 hexlobe driver shaf was broken due to the unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for viper2 t20 hexlobe driver shaf was conducted identifying that lot number so2028626 was released in a single batch.Batch1: lot qty of 115 units were released on 05 apr 2017 with no discrepancies.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

• Brand Name: VIPER2 T20 HEXLOBE DRIVER SHAF
• Common Device Name: DRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12333607
• Report Number: 1526439-2021-01717
• Device Sequence Number: 16818264
• Product Code: HWR
• UDI-Device Identifier: 10705034214290
• UDI-Public: (01)10705034214290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 286725020
• Device Catalogue Number: 286725020
• Device Lot Number: SO2028626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; UNKNOWN SCREWS