MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS ALIGNMENT DEVICE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	279726400
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Device history lot - a review of the receiving inspection (ri) for mis alignment device was conducted identifying that lot number gm5067601 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 19 jul 2018 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.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.
Event or Problem Description
It was reported that on (b)(6) 2021, alignment guide did not allow smooth cannula insertion.Guide was inspected for residual cement before insertion and cannula passed through without issue outside of screw engagement.When alignment device was inserted into screws then resistance became an issue.Cannula was damaged and bent upon removal and in two instances fractured.All of this was experienced with multiple (x6) cannulas despite readjustment and ensuring alignment and engagement into screw was as per surgical technique and as assessed by those present who all have knowledge and experience of using these instruments.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) mis alignment device.This is report 1 of 2 for complaint (b)(4).
Event or Problem Description
Procedure was completed successfully using other alignment devices.Patient is recovering as expected.This is report 1 of 7 for complaint (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.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: MIS ALIGNMENT DEVICE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle, PA ; SZ ; 6103142063
• MDR Report Key: 12952922
• Report Number: 1526439-2021-02506
• Device Sequence Number: 17440407
• Product Code: LXH
• UDI-Device Identifier: 10705034199481
• UDI-Public: (01)10705034199481
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2021

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: 279726400
• Device Catalogue Number: 279726400
• Device Lot Number: GM5067601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN EXTRACTION INSTRUMENTS; UNKNOWN SCREWS; UNKNOWN SCREWS
• Patient Sex: Unknown