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

Model Number	08.501.001.01S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Expiration date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.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 or Problem Description
It was reported that on an unknown date, two (2) sternal zipfix with needle were not fastening correctly.The sternal zipfix with needle come in a pack of twenty (20).The procedure outcome was not affected.Surgery was delayed for approximately 2-5 minutes.The surgery was successfully completed.Patient status was unknown.This report involves one (1) sternal zipfix with needle sterile.This is report 2 of 2 for (b)(4).
Event or Problem Description
Updated event description: it was reported that on an unknown date, five (5) out of 20/pack sternal zipfix with needle were not fastening correctly.The procedure outcome was not affected.Surgery was delayed for approximately 2-5 minutes.The surgery was successfully completed.Patient status was unknown.During manufacturer's preliminary investigation of the returned devices, it was identified that one (1) sternal zipfix with needle/single pack was broken.This product condition was assessed and determined to be reportable on (b)(6) 2020.This is report 2 of 2 for (b)(4).
Additional 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.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.
Additional 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, h6: visual inspection: sternal zipfix with needle sterile/20 pack was received at us customer quality (cq).Upon visual inspection at cq, it is observed that the zipfix was cut (not broken) at proximal end near the locking part.The rest of the device shows no damage.Functional inspection: functional testing of the received zipfix was performed at cq.The locking part was sliding two ways on zip without locking at any point in both directions.Dimensional inspection: dimensional inspection of the received device was performed at cq.The thickness of the zipfix and the width of the zipfix was measured to be within the specification as per the drawing.Further dimensional inspection could not be performed due to the device's geometry.Document/ specification review: the following drawing(s) was reviewed; sternal zipfix w/ needle.No design issues or discrepancies were found during this investigation.Investigation conclusion: visual inspection, functional inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint cannot be confirmed as the device was cut not broken.A definitive root cause cannot be determined for the reported failure.During investigation, will not tension/ tighten was observed.A definitive root cause cannot be determined for the functional failure of the device.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
Additional 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.H3, h6: 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.

• Brand Name: STERNAL ZIPFIX WITH NEEDLE STERILE
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10021525
• Report Number: 2939274-2020-02222
• Device Sequence Number: 11466422
• Product Code: JDQ
• UDI-Device Identifier: 10887587025971
• UDI-Public: (01)10887587025971
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: 08.501.001.01S
• Device Catalogue Number: 08.501.001.01S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: 04/24/2020
• Supplement Date Received by Manufacturer: 04/07/2020; 05/08/2020; 05/08/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/06/2020; 05/08/2020; 05/08/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK