MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MINIPOLYAXIAL SCREWDRIVER; SCREWDRIVERS

Model Number	288304000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 surgery of posterior cervical fusion at c7.During the surgery, the screwdriver¿s tip was broken when inserting the screw.The screw was removed.The surgery was completed with 30-minutes delay.The patient outcome was unknown.Concomitant device reported.Unknown screws (part# unknown, lot# unknown, qty unknown).This complaint involves one (1) device.This report is for (1) minipolyaxial screwdriver.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9 h3, h6: a review of the receiving inspection (ri) for minipolyaxial screwdriver was conducted identifying that lot number x0910 was released in three batches.Batch1: lot qty of (b)(4) units were released on 01 oct 2010 with no discrepancies.Batch2 lot qty of (b)(4) units were released on 30 sep 2010 with no discrepancies.Batch3 lot qty of (b)(4) units were released on 30 sep 2010 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.The product was returned to us customer quality (cq) for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that minipolyaxial screwdriver tip of the device was twisted and slightly broken off.No other issues were identified.The dimensional inspection was not performed due to the post-manufacturing damage.The observed condition of the minipolyaxial screwdriver 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 minipolyaxial screwdriver.While no definitive root cause could be determined, it is probable that minipolyaxial screwdriver 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.Drawing/specifications reviewed? the following drawing reflecting the current and manufacture revision was reviewed: assembly mountaineer polyaxial screwdriver 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: MINIPOLYAXIAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12100162
• Report Number: 1526439-2021-01373
• Device Sequence Number: 14506994
• Product Code: HXX
• UDI-Device Identifier: 10705034221298
• UDI-Public: 10705034221298
• 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): 06/09/2021

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: 288304000
• Device Catalogue Number: 288304000
• Device Lot Number: X0910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWS; X15 TORQUE DRIVER