MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR LS SCREW 3.5X32; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188320332
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The following was reported: problem with neck screws mountaineer, product 1883-20-332, quantity - 2 pcs.Operation date - (b)(6) 2019.Hospital - operating room of the neurosurgery unit of (b)(6) institute of ambulance by (b)(6).Problem description: neck screws were implanted in 2018, and after one year they were broken in patient.On (b)(6) 2019 broken screws were removed.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).(b)(6).((b)(4).The mountaineer ls screw 3.5x32 was received by the customer quality unit for evaluation.The screw was found to have broken at the proximal end of the shank.Fracture analysis was subsequently performed on the screw.Optical imaging of the fracture site shows two surface morphologies, a smooth region and a rough region with progression lines that are indicative of fatigue failure.This implies that the fracture initiated near one end and then propagated through the body of the shank across its axial plane to full failure/breakage near the opposing side, presumably when the strength of the remaining material was insufficient to bear the load.A review of the device history record found no issues that may have cause or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the screw breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a potential root cause may be a fatigue failure.This may have occurred due to forces placed on the screw repeatedly, resulting in the fracture first propagating across the shank and then full failure/breakage taking place when the strength of the remaining region did not have the strength to bear the load.As no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Therefore, 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: MNTR LS SCREW 3.5X32
• 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
• MDR Report Key: 8578926
• Report Number: 1526439-2019-51608
• Device Sequence Number: 16553895
• Product Code: NKG
• UDI-Device Identifier: 10705034158143
• UDI-Public: (01)10705034158143
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 188320332
• Device Catalogue Number: 188320332
• Device Lot Number: AVLDD8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 06/17/2019; 07/08/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/27/2019; 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention