MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH AIM-ARM 125 F/STAT+DYN DIST LOCK; ROD,FIXATION,INTRAMEDULLARY

Catalog Number	03.037.114
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	01/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2020, the patient underwent a surgery for the femoral trochanteric fracture with the aiming arms (03.037.114, 03.037.113) and the flexible screwdriver in question.During the surgery, the surgeon felt difficulty using the aiming arms because they were too heavy.And he thought that only the part of the flexible driver around 20 mm from the tip needed to be bent.He could not connect the driver to other devices without making more incision of 10cm and adducting the affected leg because the whole screwdriver bent.The surgery completed within a thirty (30) minute surgical delay.No further information is available.This is report 1 of 3 for (b)(4).

• Brand Name: AIM-ARM 125 F/STAT+DYN DIST LOCK
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9720382
• Report Number: 8030965-2020-01193
• Device Sequence Number: 13535459
• Product Code: HSB
• UDI-Device Identifier: 07611819642676
• UDI-Public: (01)07611819642676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.037.114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 02/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention