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

Catalog Number	03.019.024
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
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.Additional narrative: additional device product codes: hrs and hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2021, the patient underwent the surgery using the multiloc nail for humerus.The surgery was completed successfully without any surgical delay.After the surgery, the removal of the nail surgery was performed on (b)(6) 2022, for unknown reason with the extraction screw.In the removal surgery, the extraction screw did not connect well to the nail.The surgeon was able to somehow connect the extraction screw to the nail by digging quite a bit the surroundings of the nail with a paul mysel chisel.The surgery was completed successfully with 120 minutes delay.Initially planned surgery time was 60 minutes but ended up taking 180 minutes.The surgeon considered that the shape of the extraction screw had a negative effect because the other company's product had never had a trouble at removal like this, although the nail had been implanted slightly deeper than usual.The surgeon mentioned that it takes time to remove nails because of the shape of extraction screw.This report involves one (1) extraction screw for multiloc humeral nailing system.This is report 2 of 2 for (b)(4).This product complaint, (b)(4), is related to (b)(4) which is about the removal which occurred after the first surgery.This pc reports about the event which occurred in the revision surgery.

• Brand Name: EXTRACTION SCREW FOR MULTILOC HUMERAL NAILING SYSTEM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14632562
• Report Number: 8030965-2022-03802
• Device Sequence Number: 20317687
• Product Code: HSB
• UDI-Device Identifier: 07611819427242
• UDI-Public: 07611819427242
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CONSTRUCTS: MULTILOC HUMERAL NAIL
• Patient Age: 61 YR
• Patient Sex: Female