MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X16; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	1020-35-116S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: kwp.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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.The dhr of product code: 102035116s.Lot : 307527 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 25.06.2021 qty: (b)(4).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
During a cervical spine surgery with symp c2-th2 the crew ref # 1020-35-116s lot # 307527 could not be picked up orthograde with the screwdriver shaft (ref # 202033400 lot # (b)(4) and sleeve (ref # 202000401 lot # (b)(4)) from the sterile tube.The screw had to be taken out of the tube manually.But even after this, several attempts were made to record the screw orthogradely.Only a 100% correct pick-up enables the screw to be screwed in orthogradely.Therefore, insertion with the ratchet handle (ref # 202000501) was also not possible, because the use of the ratchet handle requires 100% connection of the screw with the screwdriver shaft.Surgery delay: 30min.Surgery completed successfully without any patient harm or consequences.No allegation against the mentioned instruments: screwdriver shaft (ref # 202033400 lot # (b)(4)) not available for return.Sleeve (ref # 202000401 lot # (b)(4)) not available for return.Ratchet handle (ref # 202000501) not available for return.Concomitant device reported: poly screw driver shft x20 (part# 202033400, lot# (b)(4), quantity unknown).Poly screw driver reten sleeve (part# 202000401, lot# (b)(4), quantity unknown) ao handle medium w ratchet (part# 202000501, lot# unknown, quantity unknown).This complaint involves one (1) device.

• Brand Name: 4.0 PLY SCRW 3.5X16
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12961682
• Report Number: 1526439-2021-02519
• Device Sequence Number: 13885244
• Product Code: NKG
• UDI-Device Identifier: 10705034524382
• UDI-Public: 10705034524382
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1020-35-116S
• Device Catalogue Number: 102035116S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AO HANDLE MEDIUM W RATCHET; POLY SCREW DRIVER RETEN SLEEVE; POLY SCREW DRIVER SHFT X20
• Patient Sex: Male