MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXP 6.35 CLOSED POLY DRIVER; DRIVER, PROSTHESIS

Model Number	279718101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
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
It was reported that on (b)(6) 2019, the t27 closed head expedium 6.35 screw driver broken during surgery.Surgical delay and procedure outcome are unknown.There was no patient harm/consequence.This complaint involves one (1) device.
Additional Manufacturer Narrative
(b)(4).Investigation summary: background: it was reported that on september 23, 2019, the t27 closed head expedium 6.35 screw driver broken during surgery.Surgical delay and procedure outcome are unknown.There was no patient harm/consequence.This complaint involves one (1) device.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the images provided.The images were reviewed, and the expedium closed polyaxial t27 screwdriver assembly distal external driveform feature was found broken.The complaint condition of broken is confirmed.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation was not performed since no lot number was provided.Furthermore, the device defect displays no evidence supporting a relationship between the defect and a manufacturing-related issue.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 (based on the images) 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date received by mfr: correction.

• Brand Name: EXP 6.35 CLOSED POLY DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9204657
• Report Number: 1526439-2019-52256
• Device Sequence Number: 16791638
• Product Code: HWR
• UDI-Device Identifier: 10705034301396
• UDI-Public: (01)10705034301396
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2019

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: 279718101
• Device Catalogue Number: 279718101
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 11/30/2019; 10/31/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 10/31/2019; 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1