MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STERNAL ZIPFIX WITH NEEDLE STERILE; CERCLAGE FIXATION

Catalog Number 08.501.001.01S

Device Problem Device Difficult to Maintain (3134)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.The investigation could not be completed; 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

It was reported that on (b)(6) 2019, during an unknown procedure a sternal zipfix with needle polyether ether ketone (peek) could not be tightened.Thus, the surgeon cut the sternal zipfix and was replaced with a new one in order to complete the surgery.There were no surgical delay and adverse consequences to the patient reported.Patient was stable after the operation.This complaint involves (1) device.

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.H10 additional narrative: h3, h4, h6: a review of the device history record, device history lot, part: 08.501.001.01s, lot: l226899, manufacturing site: bettlach, supplier: (b)(4), release to warehouse date: 18 january 2017, expiry date: 01 january 2022.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Only top level of the device history record reviewed as sub-components are not lot tracked.H3, h6: investigation summary; pd investigation site: sustaining engineering zuchwil / trauma/cmf - eu for detailed investigation see attached investigation report from sustaining engineering zuchwil under notes & attachments.Summary of the pd investigation: sustaining engineering did not identify any design related root cause for this intraoperative device failure.The device failure is end-user related.As per the system technique guide - step 2 the needle must be removed at the wider body section accordingly to the technique guide.Should the end user not follow this step, he/she can insert the device cut-end into the device locking housing in an angle.This misalignment can damage the locking feature within the housing and result in a loose device.(will not hold, broken, loose) the saved off material on the second device returned shows that the user did not correctly aligned the instrument with the implant as per the technique guide instructions.Therefore, this non-manufacturing investigation is closed by sustaining engineering as not-valid since the device failure is end-user related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
• Type of Device: CERCLAGE FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8676262
• MDR Text Key: 147318534
• Report Number: 8030965-2019-65024
• Device Sequence Number: 1
• Product Code: JDQ
• UDI-Device Identifier: 07611819418400
• UDI-Public: (01)07611819418400
• 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: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 08.501.001.01S
• Device Lot Number: L226899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Date Manufacturer Received: 06/14/2019
• Patient Sequence Number: 1