MAUDE Adverse Event Report: SYNTHES HAGENDORF PROTECT SLEEVE 12/8 L188; MISC ORTHO SURGICAL INSTRUMENT

Catalog Number 03.010.063

Device Problem Fitting Problem (2183)

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

Event Date 12/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that: dhr review for: part: 03.010.063 lot: 3767977.Manufacturing location: (b)(4).Manufacturing date: 08.June 2011.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2016 was a surgery to treat a femur fracture.The surgeon was not able to insert a protection sleeve smoothly into insertion handle.By turning simultaneously, he pushed in the sleeve.But the sleeve was pushed in for only 2,3 cm and stuck there.He pulled out the sleeve and found scratches along the circumference.He thinks the scratches may have made while he was turning the sleeve.Also he found burrs inside the insertion handle.He did not hammer the sleeve.The surgery was prolonged by 20 minutes.The amount of bleeding increased due to the extension of surgery.Complaint involves 2 parts.This report is 2 of 2 for com-(b)(4).

Manufacturer Narrative

Additional narrative: a product evaluation was performed.The investigation of the complaint articles indicates that the: 03.010.063 / protection sleeve.The protection sleeve is stuck in the location bore of the insertion handle.There are visible marks and scratches caused from the above described damage on the run-in of the location bore.All described nonconformities/damages are not related to the manufacturing process but caused during mechanical mishandling.The relevant outside diameter has been measured and found to meet the specifications.No manufacturing related issues on both devices were found.The root cause is determined to be excessive use and mechanical overloading.The location bore of the insertion handle was deformed because of mechanical mishandling.No manufacturing related issues on both devices were found.The root cause is determined to be excessive use and mechanical overloading.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: PROTECT SLEEVE 12/8 L188
• Type of Device: MISC ORTHO SURGICAL INSTRUMENT
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6205862
• MDR Text Key: 63372567
• Report Number: 3003875359-2016-10665
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819760905
• UDI-Public: (01)07611819760905(10)3767977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• 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: 3767977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2011
• 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
• Patient Age: 65 YR