MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 08.501.001.05S

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Synthes employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Patient code no code available used to capture the patient¿s sternum closure surgery.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 reports an event in (b)(6) as follows: during the surgery when they tried to put the band for sternum closure, the band got slipped and didn't got tighten even after using the applicator.Procedure got completed with similar product.Surgery was delayed 25 minutes.Patient is doing well now.This is report 1 for 1 (b)(4).Concomitant device reported: unknown applicator for zipfix implants (part #: unknown, lot #: unknown, quantity # :1).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot.Part: 08.501.001.05s.Lot: 2l76660.Manufacturing site: bettlach.Release to warehouse date: mar 04, 2019.Expiry date: feb 01, 2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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: STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9141854
• MDR Text Key: 160873002
• Report Number: 8030965-2019-68898
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819432505
• UDI-Public: (01)07611819432505
• Combination Product (y/n): N
• PMA/PMN Number: K110789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/06/2019

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 Expiration Date: 02/01/2024
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: 2L76660
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - TENSIONING INSTRUMENTS