MAUDE Adverse Event Report: SYNTHES HAGENDORF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX; CERCLAGE FIXATION

Catalog Number 03.501.080

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: no patient involvement reported.Event date: unknown.Device is an instrument and is not implanted/explanted.Manufacturing date: 19november2012.Manufacturing location: (b)(4).Device part 03.501.080, lot 8159385 is a batch number controlled product, therefore, no service history record review is possible.Device history record (dhr) review result below: no non-conformance reports reworks or other relevant quality notifications were referenced in the device history record.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 conclusion of the dhr review is that the final product, met inspection records, certification test values, and acceptance criteria.A product investigation was completed: the service technician noted the following action taken as activity modification.The device has been serviced and functional testing has been performed in accordance with the service manual.During the pre-repair diagnostic assessment the service technician identified the following failure code as update / upgrade.The service technician could find no fault with the device, there is no previous history in the dhr and all testing passed.The device was returned to the customer.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: during a service and evaluation for this product technician noted an update/upgrade was needed; also, two (2) sidebolts and a nut were loose.There were no injuries, patient user involvement or surgery delay or medical intervention reported.This is report 1 of 1 for (b)(4).

• Brand Name: APPLICATION INSTRUMENT FOR 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5267399
• MDR Text Key: 32685517
• Report Number: 3003875359-2015-10512
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.501.080
• Device Lot Number: 8159385
• Other Device ID Number: (01)07611819418424(10)8159385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• 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