MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC . REAMING ROD PUSH ROD WITH . BALL HANDLE; REAMER

Model Number 03.010.093

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that during an inspection, it was discovered that the shaft part of the reaming rod-push rod is too big and unable to penetrate the synream reaming shaft because of wrong size.There was no patient consequence.Concomitant device reported: flexible shaft (part# 352.040, lot# unknown, quantity # 1).This complaint involves one (2) device.This is report 2 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D10: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and/or 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.

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.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.

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.H10 additional narrative: h3, h4, h6: part: 03.010.093, lot: t185528.Manufacturing site: tuttlingen.Release to warehouse date: july 25, 2019.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The complaint device was evaluated and investigated by the manufacturer.Visual inspection: the rod pusher f/reamrod w/hex-screwdriver ø was inspected by the manufacturer.The manufacturer reported that the device was delivered in one sealable bag.The devices appeared in good condition with no damage or signs of use.Functional test: a functional assessment was not performed as the counterpart synream flexshaft (352.040) was not returned.Dimensional inspection: manufacturer performed dimension inspection per the manufactured drawings.All measurements were within tolerance.Drawing/specification review: reaming rod push rod with ball handle.Investigation conclusion: this complaint is not confirmed as the rod pusher f/reamrod w/hex-screwdriver ø was investigated and there was no issue or concern reported.The device conformed to dimensional and visual specifications at the time of manufacturing and passed inspection requirements with no non-conformities no root cause could definitively be determined for the reported complaint condition.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 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: . REAMING ROD PUSH ROD WITH . BALL HANDLE
• Type of Device: REAMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9953969
• MDR Text Key: 188214217
• Report Number: 2939274-2020-01809
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982067647
• UDI-Public: (01)10886982067647
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.093
• Device Catalogue Number: 03.010.093
• Device Lot Number: T185528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROD PUSHER F/REAMROD W/HEX-SCREWDRIVER Ø; ROD PUSHER F/REAMROD W/HEX-SCREWDRIVER Ø; SYNREAM FLEXSHAFT