MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH RETRACTOR HANDLE

Catalog Number 03.809.900

Device Problem Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review / investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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 Description

Device report from synthes europe reports an event in (b)(6) as follows: the product is missing a screw, which does not allow the valves to be placed in the retractor.The separator could not be used at the time of surgery and therefore the implant could not be placed, the retractor was fundamental for its placement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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.

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, h4, h6 investigation summary.Visual inspection: the oracle retractor handle (part # 03.809.900/ lot #3126159) was received at us cq.The retractor was missing a screw from its lever arm ¿ left.The guide arm was in its retracted position when received but was able to extend.The lever arm-right had a loose screw and appeared to be functionally loose.The lever arm would rotate with a light application of force.The missing component was confirmed.Functional test: no mating devices were returned with the retractor so it was not possible to functionally test with mating devices.Functionally testing the retractor by itself showed that the lever-arm right side was functionally loose.As the device was retracted/protracted, the lever-arm right did not hold its position and would freely rotate.This may be due to the loose screw identified on the lever-arm right.The guide arm was received in its retracted position but was able to extend after engaging the button.The rest of the device functioned smoothly and as intended.The device interaction issue was confirmed due to the noted functional issue.The received condition was consistent with the complaint condition thus the complaint was confirmed.Can the complaint be replicated with the returned device(s)? unable to perform since no mating devices were returned but due to the identified functional loose issue, the complaint was confirmed.Dimensional inspection: dimensional inspection was not performed due to definitive finding of missing components.Due to the nature of the assembly analysis of the lever-arm right was not possible due to a lack of access to internal components.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).No issues determined.Conclusion: the overall complaint was confirmed for the received oracle retractor handle (part # 03.809.900/ lot #3126159) as a screw was missing from its lever arm ¿ left and the lever arm ¿ right was functionally loose.Although no definitive root-cause can be determined it¿s possible the screw came undone at some point during the device¿s long life-cycle (10+ yrs).The screws on the lever arm ¿ right may have loosened through repetitive use and sterilization cycles.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: part: 03.809.900; lot: 3126159; manufacturing site: hägendorf; release to warehouse date: 14.May 2009.H11 corrected data; g1.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

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.H6: patient code 3191 added to capture: the reported event required medical/surgical intervention to preclude permanent damage to a body structure.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 Description

Device report from synthes europe reports an event in argentina as follows: during a cage oracle lumbar surgery lateral, it was discovered that the product is missing a screw, which does not allow the valves to be placed in the retractor.The separator could not be used at the time of surgery and therefore the implant could not be placed, the retractor was fundamental for its placement.It was decided not to make the implant placement, therefore, there will be no reprogram date scheduled.This complaint involves one (1) oracle retractor handle.

• Brand Name: RETRACTOR HANDLE
• Type of Device: RETRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9106408
• MDR Text Key: 160152459
• Report Number: 8030965-2019-68556
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 07611819923515
• UDI-Public: (01)07611819923515
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.809.900
• Device Lot Number: 3126159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Date Manufacturer Received: 11/20/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention