MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL; MISC ORTHO SURGICAL INSTR

Catalog Number	03.607.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the patient underwent revision surgery due to disengagement of the two (2) unknown screw heads on the top right and one (1) unknown screw head on the top left of the construct from an unknown screw shafts.Initially, the patient was revised to an existing universal spine systems (uss) poly construct (3 level) was prolonged (2 level) to achieve spinal fusion on (b)(6) 2019.During revision, three (3) the uss ii polyaxial screw holders broke off.They broke like a spiral fracture on their shaft.The procedure was completed successfully with a 120-minutes surgical delay reported.Patient status is unknown.This (b)(4) captures the intra-operative event during revision surgery on (b)(6) 2019 which involved the three (3) uss ii polyaxial screw holder broke off during the procedure while related complaint (b)(4) captures the postoperative events that involved disengagement of the screw heads on the top right and screw head on the top left of the construct from an unknown screw shafts; (b)(4) captures the intraoperative event during revision on (b)(6) 2019 that involved three devices that a metallic click was audible while (b)(4) captures the postoperative events where in three (3) unknown screws were replaced with 8mm screws and four (4) additional 7.0mm screws were implanted to prolong the construct on (b)(6) 2019 due to adjacent level problems.Concomitant devices reported: unknown screw heads (part# unknown.Lot# unknown, quantity unknown), unknown rod (part# unknown.Lot#unknown, quantity 1); rod crimping pliers for uss implants (part# 388.490, lot# unknown, quantity 1); uss ii polyaxial rod introduction pliers for rods (part# 03.607.009, lot# unknown, quantity #1); socket wrench t-handle (part# 388.143, lot# unknown, quantity 1) socket wrench l handle ( part# 388.584, lot # unknown,quantity of 1).This report is for one (1) polyaxial head holder for uss polyaxial.This is report 3 of 3 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.H10 additional narrative: h3, h6: investigation summary picture review: narrative (screw loosening and cracked uss-ii polyaxial 3d-head) could be verified from provided x-rays and video.Additional data-b5 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, the patient underwent revision surgery due to disengagement of the two (2) unknown screw heads on the top right and one (1) unknown screw head on the top left of the construct from an unknown screw shafts.Initially, the patient was revised to an existing universal spine systems (uss) poly construct (3 level) was prolonged (2 level) to achieve spinal fusion on (b)(6), 2019.During revision, the uss ii polyaxial screw holder broke off.They broke like a spiral fracture on their shaft.The procedure was completed successfully with a 120-minutes surgical delay reported.Patient status is unknown.Concomitant devices reported: unknown screw heads (part# unknown.Lot# unknown, quantity unknown), unknown rod (part# unknown.Lot#unknown, quantity 1); rod crimping pliers for uss implants (part# 388.490, lot# unknown, quantity 1); uss ii polyaxial rod introduction pliers for rods (part# 03.607.009, lot# unknown, quantity #1); socket wrench t-handle (part# 388.143, lot# unknown, quantity 1) socket wrench l handle ( part# 388.584, lot # unknown,quantity of 1) this is report 3 of 7 for (b)(4).

• Brand Name: POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8608512
• Report Number: 8030965-2019-63919
• Device Sequence Number: 16729097
• Product Code: LXH
• UDI-Device Identifier: 07611819185418
• UDI-Public: (01)07611819185418
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/15/2019

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 Catalogue Number: 03.607.005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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: SOCKET-WRENCH Ø5 W/T-HANDLE; UNK - MONO/POLY SCR COLLARS/HEADS: USS; UNK - RODS: SPINE; USS ROD CRIMPING PLIERS F/IMPL SIDE-OPEN; USS-II POLYAX ROD INTRODUCTPLIERS
• Patient Age: 65 YR
• Patient Weight: 95