MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH APPLICATION INSTRUMENT FO STERNAL ZIPFIX; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 03.501.080

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 surgery of dr utpal shah, while cutting the zipfix band the cutter of the applicator gave away and the zipfix band could not be cut.Concomitant device reported: unk - zipfix implants (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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.Visual inspection: the application instrument for sternal zipfix was received showing a portion of the cutter component broken off.The broken part is missing.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: due to the missing part and the condition of the returned device, a dimensional test is not appropriate, as all complaint-relevant dimensions cannot be measured and can no longer correspond to the valid technical drawings specifications due to the damage incurred.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the complaint condition is confirmed as the received device was found broken.During the performed evaluation no manufacturing related issue could be detected.Because of the damage and the missing broken part, the for the complaint relevant dimensions cannot be measured anymore.It is likely that a mechanical overload situation during use lead to the breakage.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history part: 03.501.080, lot: 9790420, manufacturing site: hägendorf, release to warehouse date: 31.Mar.2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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: APPLICATION INSTRUMENT FO STERNAL ZIPFIX
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9613542
• MDR Text Key: 194807989
• Report Number: 8030965-2020-00532
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 07611819418424
• UDI-Public: (01)07611819418424
• Combination Product (y/n): N
• PMA/PMN Number: K11078
• 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: 12/27/2019

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 Catalogue Number: 03.501.080
• Device Lot Number: 9790420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 02/04/2020
• Supplement Dates FDA Received: 02/25/2020
• Patient Sequence Number: 1
• Treatment: UNK - ZIPFIX IMPLANTS