MAUDE Adverse Event Report: SYNTHES HAGENDORF AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.019.008

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Manufacturing location: (b)(4).Manufacturing date: august 12, 2013.Neither deviation nor any non-conformance reports were marked in the device history record.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 Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the device was used in surgery for the proximal humeral fractures on (b)(6) 2016.The surgeon used a left multiloc humeral nail.After he fixed distal bone fragments, he started drilling with an ascending screw.When he reviewed lateral images, he noticed that the screw came off to the frontal side of the nail.By viewing lateral images simultaneously, he manually put pressure onto the tip of the sleeve.Then he aligned the nail and sleeve like the surelock system.The surgery was completed.The surgery was extended for five (5) minutes.Concomitant parts: nail (part unknown, lot unknown, quantity 1); drill bit (part unknown, lot unknown, quantity 1); sleeve (part unknown, lot unknown, quantity 1).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Manufacturing evaluation was performed for part # 03.019.008, lot # 8346855.One (1) article of aiming arm was received for manufacturing investigation.The article received was in a used condition.Slight traces of use were visible inside guiding holes ø12 mm and ø13 mm.During manufacturing investigation, all relevant and significant characteristics like dimensions and functions were checked.All measured characteristics are within the specifications and the aiming arm passed the functional tests.There were no references to the reported issue.No manufacturing related issue was identified and/or confirmed.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: AIMING ARM/LAT/F/MULTILOC PROXIMAL HUMERAL NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6107008
• MDR Text Key: 60098420
• Report Number: 3003875359-2016-10597
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.019.008
• Device Lot Number: 8346855
• Other Device ID Number: (01)07611819425583(10)8346855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 UNKNOWN DRILL BIT; 1 UNKNOWN NAIL; 1 UNKNOWN SLEEVE