MAUDE Adverse Event Report: SYNTHES HAGENDORF AIM-ARM 125° F/STAT+DYN DIST LOCK; GUIDE

Catalog Number	03.037.114
Medical Device Problem Codes	Fitting Problem (2183); Failure to Align (2522)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.(b)(6).510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: jan 13, 2016.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformance reports (ncrs) were generated during the production of the subject device.Patient code (b)(4) was utilized for additional medical intervention.The guide sleeve and aiming arm became stuck which made it difficult to obtain proper measurements for the blade length.The surgeon was able to obtain the correct measurements after a several attempts and a 30 minute surgical delay.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
Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery to treat fractures proximal femur and femoral shaft on (b)(6) 2017, the aiming arm and guide wire sleeve became stuck together.The surgeon had first inserted the nail then the guide wire sleeve was inserted into the aiming arm.In order to adjust nailing depth, the surgeon tried to remove the buttress compression nut from the aiming arm.This is when the aiming arm and guide wire sleeve engaged and became stuck.This engagement happened to generate a gap between the guide wire sleeve and the outer cortical bone.In this unstable surgical atmosphere, taking measurements of the blade length became inaccurate.Thus, the surgeon replaced two blades and completed the surgery with a 30 minute delay.After the procedure, while cleaning the engaged aiming arm and guide wire sleeve, the nurse hammed the stuck section and was able to detach the guide wire sleeve.Concomitant device: 1x unk nail, 1x unk compression nut, 1x unk blade.This report is 1 of 2 for (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed for the subject device (aim-arm 125° f/stat+dyn dist lock, part number 03.037.114, lot number 6451382).The subject device was returned with the complaint condition stating 9705618: carried out functional test shows good functionality of the parts.Parts could be locked and unlocked as intended.We could not reproduce the reported problem.No product fault could be identified.We are not able to reproduce the reported problem and to identify the exact root cause for the reported problem.The complaint was not confirmed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(6).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: AIM-ARM 125° F/STAT+DYN DIST LOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6557001
• Report Number: 3003875359-2017-10225
• Device Sequence Number: 649968
• Product Code: FZX
• UDI-Device Identifier: 07611819642676
• UDI-Public: (01)07611819642676(10)9705618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/11/2017

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
• Device Lot Number: 9705618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/07/2017; 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BLADE, QTY. 1; UNKNOWN COMPRESSION NUT, QTY. 1
• Outcome Attributed to Adverse Event: Required Intervention