MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH OPAL IMPLANT HOLDER STRAIGHT; MISC ORTHO SURGICAL INSTRUMEN

Model Number	03.803.001
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Complainant device is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested and is currently pending completion.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during a posterior spinal fusion procedure, the surgeon was using the opal implant holder straight.After inserting the first opal implant successfully, the surgeon could not get the knob to release from the sleeve.It is unknown if there was a surgical delay.There was no patient consequence reported.Concomitant device reported: unknown opal implant (part # unknown, lot # unknown, quantity # unknown).This complaint involves one (1) device.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.Part: 03.803.001; synthes lot: h550250; supplier lot: h550250; release to warehouse date: may 03, 2018; supplier: avalign technologies ¿ nemcomed.No nonconformance reports (ncrs) were generated during production.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.Product was not returned.Based on the information available, it has been determined that no corrective and 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 further reported that the device is now working fine and that the surgeon and or staff had inadvertently overtightened the device while trying to loosen the knob.

• Brand Name: OPAL IMPLANT HOLDER STRAIGHT
• Common Device Name: MISC ORTHO SURGICAL INSTRUMEN
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7943128
• Report Number: 8030965-2018-57059
• Device Sequence Number: 857325
• Product Code: LXH
• UDI-Device Identifier: 10705034722443
• UDI-Public: (01)10705034722443
• Combination Product (Y/N): N
• Initial Reporter State: GU
• 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): 09/19/2018

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 Model Number: 03.803.001
• Device Catalogue Number: 03.803.001
• Device Lot Number: H550250
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1