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
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing 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.
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 2 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.The returned uss-ii polyax scrholder is broken as complained.The fracture occurred in the component part 'guiding tube' (50159976) and shows a spiral fracture pattern.The broken part was not returned.Besides, the instrument shows normal signs of use.The complaint condition is confirmed as the guiding tube of the uss-ii polyax scrholder is broken.This production lot (8955160) was manufactured in june 2014 according to the specification.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.According to the relevant test the correct material was used, and the hardness parameters were within the specification.Function test was performed at the time of manufacturing with no issues documented.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production/acceptance criterias.The damage appears to be the result of repeated use and high applied torsional strain during the 4 plus years lifetime.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 03.607.005.Lot: 8955160.Manufacturing site: hägendorf.Release to warehouse date: 25 june 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The sub-component 50159976 is not lot tracked.Therefore the last three potential work orders (9018471, 8921815 and 8807080) that were produced prior to lot 8955160 were reviewed.The review has shown that with 1.4034 the correct material was used and that the hardness was within the specification.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 april 15, 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 2 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: 8608472
• Report Number: 8030965-2019-63918
• Device Sequence Number: 16729320
• 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
• Device Lot Number: 8955160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• 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
• Patient Age: 65 YR
• Patient Weight: 95