MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLIC-INSTR F/STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Device available for evaluation?: date returned to manufacturer.Device history records review was conducted.The report indicates that the: part #03.501.080 / lot #9150675, manufacturing location: (b)(4), manufacturing date: 10 oct 2014.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.A manufacturing investigation action/summary was conducted/performed.The report indicates that: during the manufacturing investigation, it's been observed that pin ø3 x 15 mm, component 60069576, is not at the original position.In accordance to the assembly drawing, the pin should be positioned and secured by a laser welding seam.This laser welding seam is missing on both sides of the pin.Therefore, it was possible that the pin was moving and blocked the lever from correct operating.The component lever at laser welding operation was not done correctly.In total, 3 pins are getting laser welded.Two (2) pins, are laser welded correctly and on 1 pin the laser welding seam on both sides is missing.The complaint is determined to be manufacturing related.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The application instrument f/sternal zipfix was submitted for repair from affiliate in (b)(4).There were no injuries, patient user involvement or surgery delay or need for additional medical intervention reported.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

• Brand Name: APPLIC-INSTR F/STERNAL ZIPFIX
• Type of Device: CERCLAGE FIXATION
• 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: 6749060
• MDR Text Key: 81443247
• Report Number: 3003875359-2017-10354
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424(10)9150675
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K110789
• 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
• Report Date: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.501.080
• Device Lot Number: 9150675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2014
• 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