MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK; CERCLAGE FIXATION

Catalog Number 08.501.001.05S

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Date of event: it is unknown when the event occurred.Pma / 510k: this report is for an unknown number of unknown sternal zipfix devices - unknown lot; unknown part.Udi unknown.Implanted date: unknown.Complainant part has not been returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a sternal zipfix system application and implantation in the patient's body caused severe injuries as a result of product failure.No additional information was provided.This complaint involves one (1) device.

Manufacturer Narrative

Dverse event, product problem, required intervention-serious injury.Product code corrected.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) 2015 a patient underwent a procedure involving coronary artery bypass grafting, left internal mammary artery repair, a saphenous vein graft to obtuse marginal 2, and a saphenous vein graft to right posterior descending artery.The surgeon elected to complete the procedure through the right femoral artery due to the patient's coronary artery disease.The procedure was completed successfully and the surgeon implanted the patient with an unknown quantity of synthes sternal zipfix with needle devices to close the sternum.Postoperatively, it was identified that the patient presented with severe injuries as a results of product failure.

Event Description

It was identified that the device broke, splintered, or snapped either during the procedure or postoperatively, migrating from its intended placement causing pain and injury to the patient.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in 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.

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.Investigation based on provided images.(actual device not returned).Visual inspection: actual device was not returned.Visual inspection of the provided images was performed at customer quality (cq).The provided images are of the device outside of the body.No images of the device failing in-situ were provided.Based on the provided images lacking visual evidence of the device failing in situ, the reported complaint condition could not be confirmed.Dhr review: the complaint device was manufactured in december 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.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.Document/specification review: no product design issues or discrepancies were observed during this investigation.Conclusion: a definitive root cause for the reported complaint condition could not be determined based on the provided information.The reported complaint condition was not able to be confirmed and no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.Device history lot, part no.: 08.501.001.05s, lot no.: 9156571, manufacturing location: selzach, supplier: (b)(4), release to warehouse date: 10.Dec.2014, expiry date: 10.Dec.2017.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.The raw material was confirmed to be correct per the specification with no relevant non-conformance noted.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.

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.A device history record review was performed for the subject device: part no.: 08.501.001.05s , lot no.: 9156571 , manufacturing location: selzach , supplier: samaplast ag , release to warehouse date: 10.Dec.2014 , expiry date: 10.Dec.2017.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.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: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7189185
• MDR Text Key: 97286566
• Report Number: 2939274-2018-50249
• Device Sequence Number: 1
• Product Code: JDQ
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2017
• Device Catalogue Number: 08.501.001.05S
• Device Lot Number: 91565571
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 03/06/2018; 04/30/2018; 05/24/2018; 02/11/2019
• Supplement Dates FDA Received: 04/05/2018; 05/21/2018; 05/25/2018; 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 83