MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: mnh, mni, kwq, kwp.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.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 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) 2019, a patient underwent lumbar spinal fusion surgery at l4 due to lumbar burst fracture with matrix spine 5.5 system.During the surgery, when the surgeon tried to implant the pedicle screw matrix 5.5 polyaxial, the surgeon had difficulty to hold the screw with an unknown screwdriver.The, surgeon then recognized that the screw head seemed to be deformed.The surgery was completed by using an alternative screw.After the surgery, the surgeon found out that the screw thread was broken.All fragments were removed from the patient.There was no surgical delay.There was no adverse consequence and patient was stable.This complaint involves one (1) pedicscr matrix 5.5 polyaxial.This report is 1 of 1 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.Additional narrative: added concomiatnt device.Concomitant medical products.Initial reporter occupation.A device history record (dhr) review was conducted: this mre review is for sterilization procedure only part: 04.632.750s, lot: l163031, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: 13.October 2016, expiry date: 01.October 2026.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in monument part: 04.632.750, lot: h156418, a dhr review was not performed for this pi.This lot was manufactured by brandywine.Please reassign to the correct group a product investigation was conducted.Visual inspection: the pedicle screw matrix 5.5 polyaxial (part # 04.632.750s, lot # l163031, mfg # 13-oct-2016) was received at us cq with the screw head deformed and material missing from the threaded portion of the screw head.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was not performed as relevant features are deformed with missing material.Document/specification review: the relevant drawing(s) was reviewed; conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.Corrected data 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
Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1).
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.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: PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8640083
• Report Number: 8030965-2019-64507
• Device Sequence Number: 2017020
• Product Code: NKB
• UDI-Device Identifier: 10705034745688
• UDI-Public: (01)10705034745688
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2019

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 Expiration Date: 10/01/2026
• Device Model Number: 04.632.750
• Device Catalogue Number: 04.632.750S
• Device Lot Number: L163031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/27/2019; 06/24/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 06/24/2019; 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS