MAUDE Adverse Event Report: RTI SURGICAL PROVISIONAL TENSIONING DEVICE; MISC ORTHO SURGICAL INSTR

Catalog Number	391.884
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during the surgery the temporary tension holding device (391.884) was not holding tension.The procedure was completed successfully without delay.There was no fragment generated and decided to not use temporary tensioner and just crimp and lock tension straightaway.There were no patient consequences.This complaint involves one (1) device.This report is for (1) provisional tensioning device.This report is 1 of 1 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.H10 additional narrative: 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.
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, h4, h6 investigation summary: the complaint device was evaluated and investigated at the supplier, rti surgical/pioneer surgical.See pi attachment in complaint.Investigation flow: device interaction/functional.Visual inspection: the tension holder f/temp-use (part #: 391.884, lot #: p126668) inspected by rti.The visual inspection found the coil spring to be missing.No other non-conformity was reported.Functional test: a functional assessment was performed and passed.The functional test was strictly testing the locking/holding power of the device (cam lever clamping/holding on cable).The coil spring was not needed to perform the functional testing as it is simply to keep the rear bit retained on the tensioner during use.Can the complaint be replicated with the returned device? compliant could not be replicated as the device passed the functional testing.Dimensional inspection: no dimensional inspection was performed because the complaint was not able to replicate and the device passed functional testing.Document/specification review: (current) and (manufactured) were documents were reviewed.A dhr review was conducted by the supplier and it revealed that the device met manufacturing specification prior to shipping.Also, a review of past complaints has determined this to be the 4th occurrence, within the last 12 months, associated with the canted coil spring dislodging from the tensioning device.Based on total depuy synthes units sold for the past 12 months, the complaint rate for this occurrence is <0.01% no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed for the tension holder f/temp-use (part #: 391.884, lot #: p126668) as the device passed functional testing and operated as intended.However the supplier reported that the device was returned without the coil spring which is intended to help keeping the rear bit retained on the tensioner during use.No root cause could definitively be determined for the reported complaint condition but it is likely due to maintenance.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history: part #: 391.884; synthes lot number: p126668; supplier lot number: p126668; release to warehouse date: 16-aug-2012; supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.
Event or Problem Description
Event update: event occurred intraoperatively on (b)(6) 2020.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: part #: 391.884.Synthes lot number: p126668.Supplier lot number: p126668.Release to warehouse date: 16-aug-2012.Supplier: (b)(4).Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 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: PROVISIONAL TENSIONING DEVICE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 10184670
• Report Number: 1833824-2020-00055
• Device Sequence Number: 2706572
• Product Code: LXH
• UDI-Device Identifier: 07611819719859
• UDI-Public: 07611819719859
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/11/2020

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 Catalogue Number: 391.884
• Device Lot Number: P126668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/28/2020; 07/30/2020; 10/06/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 07/15/2020; 08/27/2020; 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1