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

Catalog Number 03.010.440

Device Problem Difficult to Remove (1528)

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

Event Date 08/01/2014

Event Type  malfunction  

Event Description

It was reported that the past couple of times after insertion of connection screws in a nail, it is very difficult to remove the insertion handle.It takes a lot of effort and they have had to remove the insertion handle with a wrench and a screw driver.There has been no delay in surgical time.There was no consequence to the patient.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

It was reported at least one of the times the complaint issue happened was on (b)(6) 2014.It is unknown how many other times or when this happened before.Device is an instrument and is not implanted/explanted.Without a lot number the device history records review could not be completed.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.

Manufacturer Narrative

(b)(4): no non-conformance reports 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.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

A pd evaluation was conducted.The report indicates that one insertion handle for suprapatellar was received for evaluation with complaint category "does not/will not function: sticks/jams/stuck¿ and complaint description " it was reported that the past couple of times after insertion of connection screws in nail, it is very difficult to remove the insertion handle, it takes a lot of effort, more than it should; they have had to remove the insertion handle with a wrench and a screw driver.There was no delay in surgical time.There was no consequence to the patient.The sales consultant reported that they need this equipment at the hospital for use and will return it once the replacement devices are received.Sales consultant indicated that it could be an issue with the insertion handle or the connection screw.Both parts will be returned and both require replacement.¿ the returned insertion handle was received intact.The alignment tab showed signs of wear and damage.Product drawings (03_010_440, rev b, insertion handle, suprapatellar; 03_010_440_1, rev a, insertion handle, suprapatellar; and 03_010_440_2, rev b, barrel blank, suprapatellar ) were reviewed during this evaluation.No drawing discrepancies were identified.The design is determined to be adequate for its intended use and the complaint invalid from a design perspective.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: INSERTION HANDLE FOR SUPRAPATELLAR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4043412
• MDR Text Key: 20269620
• Report Number: 2520274-2014-13324
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.440
• Device Lot Number: 12-0634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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