MAUDE Adverse Event Report: SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number 03.010.440

Device Problems Difficult to Remove (1528); Sticking (1597); Separation Failure (2547)

Patient Problem Sedation (2368)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Device is an instrument and is not implanted or explanted.(b)(4).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: october 1, 2014.Non-conformance reports (ncr) were generated during the manufacturing of the articles.One article was prepared without labeling and the package was defective.One part was dropped on the floor.A critical defect for defective packaging was also addressed.All the parts were booked in quarantine storage.Device 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 a connection screw could not be separated from an insertion handle during a surgical procedure on (b)(6), 2015.Per the reporter, several attempts were made with all of the appropriate instruments, but the devices could not be separated from one another.It was necessary for the surgeon to remove the nail and replace it with another.The procedure was prolonged by sixty (60) minutes or more.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Synthes lot number was added.The previously report lot number, 14-4638, is the supplier lot number.A manufacturing investigation was performed for the subject device.The subject device was returned along with the complained nail and connecting screw.A functional test of the received articles showed that the devices could be mounted together without any problems.The complaint issue could not be replicated.Unfortunately without more information or x-rays we are not able to determine the root cause which has led to this complaint.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERTION HANDLE FOR SUPRAPATELLAR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5180521
• MDR Text Key: 29358527
• Report Number: 3000270450-2015-10218
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111667
• 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,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.440
• Device Lot Number: U208643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 35 YR