MAUDE Adverse Event Report: SYNTHES SELZACH SCREWDRIVER INSERT FOR HEXAGONAL SOCKET; SCREWDRIVERS

Catalog Number 000000000000080048

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient information not available for reporting device is an instrument and is not implanted/explanted.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review ¿ manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 05 dec 2014 expiry date: 01 april 2024.No ncrs were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: a box was reportedly opening due to bad glue.This event caused a 15 minute surgical delay.This is report 1 of 5 for (b)(4).

Manufacturer Narrative

Manufacturing investigation evaluation: five (5) packages with screwdriver inserts received presenting some irregularities in the sealing seem after being opened/ peeled.During quality control, these articles, as well as the packages, were visually checked prior to leaving the manufacturing site.This step would ensure that an improper sealing would be detected.No non-conformities were noted for these two lot numbers.During the in-process control, no deviations were found.Tensile strength was checked and found to meet the specifications.A visual inspection was also conducted.Before opening the package, no irregularities were visible.After opening the packages, some inhomogeneity in the sealing layer was observed.A leak test with subsequent peel test was performed.The sealing seams were tight, but after peeling, some inhomogeneity in the sealing layer observed.The exact cause of failure could not be determined.However, due to the specified sealing parameters, a quite tight sealing is achieved.Upon opening, the sealing layer may get damaged, which can be recognizable as inhomogeneity.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.

• Brand Name: SCREWDRIVER INSERT FOR HEXAGONAL SOCKET
• Type of Device: SCREWDRIVERS
• 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: 5145130
• MDR Text Key: 28505868
• Report Number: 3000270450-2015-10200
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 000000000000080048
• Device Lot Number: 209121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• 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