MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH OPAL IMPLANT HOLDER PISTOL GRIP; MISC ORTHO SURGICAL INSTR

Catalog Number	03.803.002
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient underwent transforaminal lumbar interbody fusion (tlif) for l3/4 and posterior lumbar interbody fusion (plif) for l4/5 on (b)(6) 2018.During the plif surgery, two (2) pieces of unknown cages for l4/5 were implanted using the oblique posterior atraumatic lumbar (opal) implant holder pistol grip.After the implantation the lock or release knob became stuck.The surgeon then used an opal implant holder-straight to implant one (1) unknown cage for l3/4 via transforaminal lumbar interbody fusion.An x-ray was performed intra-operatively and showed that two (2) cages of l4/5 were out of position.The surgeon tried to use the opal implant holder-straight to correct the cage position but the lock or release knob became stuck.The surgeon quickly repaired the opal implant holder-straight and used it to correct the cage position.The surgical procedure was successfully completed.There was a 45-minute surgical delay.This report is for one (1) opal implant holder pistol grip.This is report 3 of 4 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.Device history lot , part # 03.803.002, synthes lot # h500013, supplier lot # h500013, release to warehouse date: 06mar2018, supplier: avalign technologies - nemcomed.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection of the sleeve, shaft, and knob components of the received implant holder instrument revealed no major damage to any component: no features of any component of the device that contact one another during hold and release of the implant were damaged.Some minor wear marks were evident on the knurled portion of the knob shell; these marks can most likely be attributed to use of gripping/leverage instruments such as an adjustable wrench.Wear was also noted from the proximal tip of the shaft to the shaft¿s groove; this feature looked polished relative to the remainder of the shaft.Minor wear marks were noted to the distal shaft where it interfaces with the sleeve during hold and release of the implant.The implant holder assembly (knob assembly, shaft, silicone handle, and sleeve assembly components) was received assembled.The knob was able to rotate completely in either direction, which operated the opening and closing of the distal end of the shaft.Some binding and noise was noted during rotation; however, it did not impede operation of the device.The wear marks noted during visual inspection did not contributed to a functional issue and are therefore considered cosmetic in nature.It was determined that the received condition did not agree with the complaint description of a jammed/seized issue during release of the implant ¿ the complaint could not be replicated with the returned device and the complaint was not confirmed.All components were able to be disassembled and reassembled during investigation.It was noted during investigation that it was difficult to disassemble the shaft from the knob assembly while depressing the button on the knob.During investigation, a jammed/seized issue occurred while assembling and disassembling the shaft from the instrument¿s knob assembly while the knob¿s button was depressed; this issue is a separate condition unrelated to the complaint condition.The diameter of the polished portion of the shaft measured 4.52mm, which was within specification.The inner diameter of the finger spring subcomponent of the knob assembly measured was below specification.Review of the device history record(s) showed that the lot went through the required steps during the inspection at the time of manufacturing and showed no issues concerning the material or material conditioning.The complaint condition is unconfirmed as the device functioned as intended.No definitive root cause was able to be determined as the situational circumstances surrounding the event are unknown and the complaint condition could not be replicated.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the received condition.The implant used during the event was not returned with the device; it is possible that the implant interacted with this instrument inappropriately due to situational issues such as soft tissue interference.The jammed/seized condition of the shaft not disassembling from the instrument¿s knob assembly could be partially attributed to the inner diameter of the finger spring component being below specification.Its important to note that this specification only applies prior to the manufacturing activity of slotting the finger spring and not the finished component.The root cause of the jammed/seized received condition of the shaft not disassembling from the instrument¿s knob assembly could not be determined during investigation.No manufacturing issues were identified during investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the received condition.It is possible, along with the narrower inner diameter of the finger spring, issues such as changes to the interfacing surface properties/geometry of the shaft and finger spring, the stiffness of the finger spring, or mechanical interference from the slide contributed to this issue.These features were not investigated as the knob assembly could not be dismantled during investigation.This issue will be monitored via post-market activities.Overall the complaint is considered confirmed due to the jammed/seized received condition of the shaft and knob assembly.Disassembly of the shaft from the knob assembly does not occur during surgical procedure; disassembly is only required for proper sterilization.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: OPAL IMPLANT HOLDER PISTOL GRIP
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7927578
• Report Number: 8030965-2018-56912
• Device Sequence Number: 13883647
• Product Code: LXH
• UDI-Device Identifier: 07611819940604
• UDI-Public: (01)07611819940604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2018

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: 03.803.002
• Device Lot Number: H500013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1