MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM; ROD,FIXATION,INTRAMEDULLARY

Catalog Number	03.019.024
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Additional product code: hwc & hrs.Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 europe reports an event in (b)(6) as follows: it was reported that the customer had difficulty in removing a multiloc nail because the threads of the extraction screw used to extract the nail are too short and do not hold the nail enough.A connection screw was used in association to the extraction screw to remove the nail.The surgery was completed successfully, but the instructions in the ifu were not followed.A 20 minutes surgical delay was reported.The patient is fine and requested the removal of the nail, no issue was reported for the nail.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device evaluated by mfr: this complaint was forwarded to the responsible pd department for a deeper investigation, including pictures, with the following results: the diameter in question is designed to act as a stop to have a tight fit between the nail and extraction screw at the proximal flat surface of the nail.The user also used the connecting screw and extraction screw together to explant the nail.According to surgical technique, the connecting screw is used in combination of insertion handle for the insertion of the nail.The inner thread of the connecting screw is used in combination with the compression screw 03.019.038.The user did not follow the instructions provided in the surgical technique.Least material condition (lmc) was simulated, and the extraction screw engages into the nail.Due to the lack of evidence and product not being returned, no further analysis can be conducted.The complaint condition is unconfirmed.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: EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7877759
• Report Number: 8030965-2018-56332
• Device Sequence Number: 2217578
• Product Code: HSB
• UDI-Device Identifier: 07611819427242
• UDI-Public: (01)07611819427242
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120807
• 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): 08/27/2018

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: 03.019.024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1