MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUNTER TORQUE; DRIVER

Model Number	2020-00-138
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, 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
It was reported that on (b)(6) 2020, the symphony torque limiting handle ¿wouldn¿t pop¿ when tightening set screws, surgeon mentioned that 3.0 mm pressure is too much for this procedure.Procedure was successfully completed.Patient outcome is unknown.Concomitant device reported: unk - set screws (part# unknown, lot# unknown, quantity 1).This complaint involves three (3) devices.This is report 1 of 3 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.H3, h4, h6: based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H3, h6: the device was received, the investigation is in progress, 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.
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.H10 additional narrative: a review of the receiving inspection (ri) for counter torque was conducted identifying that lot number km880986 was released in a single batch.-batch1: lot qty of (b)(4) units were released on december 2, 2019 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 ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Visual.Visual inspection: the counter torque (p/n: 202000138, lot #: km880986) was returned and received.Upon visual inspection, no defects were observed with the returned device.Document/specification review.Based on the date of manufacture the following drawings, the current and manufactured revision of drawings were reviewed.Counter torque.Complaint confirmed? no.Investigation conclusion: the complaint condition was not confirmed for the counter torque (p/n: 202000138, lot #: km880986).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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: COUNTER TORQUE
• Common Device Name: DRIVER
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9992508
• Report Number: 1526439-2020-00898
• Device Sequence Number: 3699671
• Product Code: HWR
• UDI-Device Identifier: 10705034530543
• UDI-Public: (01)10705034530543
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/02/2020

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: 2020-00-138
• Device Catalogue Number: 202000138
• Device Lot Number: KM880986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/14/2020; 05/29/2020
• Initial Report FDA Received Date: 04/23/2020
• Supplement Report FDA Received Date: 05/14/2020; 05/29/2020
• 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: AO HANDLE TORQ LIMITING 3.0NM; COUNTER TORQUE; UNKNOWN LOCKING/SET SCREWS; X15 DRIVER FINAL TIGHTENER
• Patient Age: 53 YR
• Patient Weight: 59