MAUDE Adverse Event Report: SYNTHES GMBH PROTECT SLEEVE 12/8 L188

Catalog Number 03.010.063

Device Problem Accessory Incompatible (1004)

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

Event Date 12/26/2013

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the multiloc proximal humeral nail was used for the fracture of surgical neck of humerus.The drill interfered with the nail, and the distal side stop screw was unable to insert.The nail was able to attach to the handle without any problem when interference check was done.Before the surgeon attempted to insert the distal side stop screw, he retightened the connecting screw by way of precaution.The length of the procedure was extended.The physician felt the drill was interfered with the nail due to the heavy backlash allowance of sleeve.The sales consultant advised the surgeon on how to reduce the possibility of interference by dissecting the soft tissues to create a clear view of the bone and by checking if the sleeve contacts with the bone by image before drilling.The physician felt the dill was interfered with the nail due to the heavy backlash allowance of sleeve.The sales consultant advised the surgeon on how to reduce the possibility of interference by dissecting the soft tissues to create a clear view of the bone and by checking if the sleeve contacts with the bone by image before drilling.This is report 5 of 6 for complaint #(b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Investigation could not be completed and no conclusion could be drawn, as product is entering the complaint system.The manufacturing documents were reviewed and no complaint related issues were found.Placeholder.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: as part of the product development evaluation a functional test was performed with the existing instruments.A nail was attached to the insertion handle and an aiming arm was assembled.The alignment of the locking holes in the nail was tested with the protection sleeve, the drill guide and the drill, no misalignment was detected.A mismatch between the incision and the protection sleeve may lead to tension by soft tissue on the protection sleeve and therefore may lead to deformation of the instrument.A distance between the drill sleeve tip and the cortex may lead to slipping of the guide wire or drill bit on the cortex and therefore may lead to a mismatch of the instrument.The present devices were analyzed for conformance to print specifications as well as the device history records were researched.No abnormal findings were identified.No product fault could be detected.

• Brand Name: PROTECT SLEEVE 12/8 L188
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer (Section G): SYNTHES GMBH; eimattstrasse 3; ch-4436; oberdorf ; SZ
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3608122
• MDR Text Key: 4065802
• Report Number: 8030965-2014-00187
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.063
• Device Lot Number: 8326173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1