MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS QC T27 POLY DRIVER; SCREWDRIVER

Model Number	279704401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
It was reported that dr.Morrison was revising a 9x100mm fully threaded iliac screw on (b)(6) 2018.The implant was loose which required it to be replaced.Dr.(b)(6) successfully removed a 9x100mm fully threaded sai screw ((b)(4)) on the right.He then proceeded to use a 10mm sai tap and tapped the full length of 100mm in the same screw hole where he removed the 9x100mm screw.He then placed the new 10x100mm screw.At 80mm he began to see increased resistance.He then took a t-handle and attached it to the sai screwdriver.Upon 5mm of additional insertion, the tip of the screwdriver broke (15mm of screw threads exposed).He tried to remove the screw by ¿helicoptering¿ the screw out using a custom device.He was unable to remove the screw.He decided to wait till friday, (b)(6) 2018 to remove the screw and replace it.The (b)(6) 2018 revision was already scheduled for implanting rods and new expedium inner screws.Patient consequence? :yes patient consequence description:additional anesthesia incurred in attempt to remove the screw (from the broken screwdriver.15 minutes.Action taken for procedure:revision 7/27/2018.Surgery was already planned for putting new rods and set screws, but dr.Morrison will have to take time to removed the 10x100mm screw, and replace it.Concomitant device : #1797-06-099, lot # unk quantity 1.
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.Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip.The second half of the driver tip was not returned for analysis.The results of the fracture analysis report reveals plastic deformation at the hexlobes and torsional shear markings following a circular pattern.This suggests that the fractured tip underwent a quasi-static overload torsional shear failure.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the driver tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure.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 and no systemic trends were found, 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: MIS QC T27 POLY DRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7784240
• Report Number: 1526439-2018-50792
• Device Sequence Number: 181819
• Product Code: HXX
• UDI-Device Identifier: 10705034438191
• UDI-Public: (01)10705034438191
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 279704401
• Device Catalogue Number: 279704401
• Device Lot Number: PC3624406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 08/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)