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

Catalog Number 03.037.114

Device Problem Device-Device Incompatibility (2919)

Patient Problem Tissue Damage (2104)

Event Date 01/24/2020

Event Type  Injury  

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 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
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9720382
• MDR Text Key: 191676282
• Report Number: 8030965-2020-01193
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819642676
• UDI-Public: (01)07611819642676
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention