MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® GUIDE SHAFT

Catalog Number	338.21
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device malfunction did occur and regardless of misuse, has caused or contributed to the need for medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The complaint indicated that the devices malfunctioned which resulted in a change in surgical plan (planned procedure was dhs, changed to dhhs) and a surgical delay of 8-10 minutes.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 during a unknown procedure on (b)(6) 2018, while the surgeon was using the dhs®/dcs® wrench, for inserting a dhs®/dcs® coupling screw, upon insertion into the femoral head, the dhs®/dcs® wrench would not disconnect and slide off from guide shaft assembly (dhs®/dcs® centering sleeve and dhs®/dcs® guide shaft).Dhs®/dcs® lag screw 12.7mm thread/95mm (part # 280.950, lot # 5522496, qty # 1) was attached to the guide shaft and coupling screw and was not able to detach because it was stuck inside of the wrench.Upon trying to disconnect it, the handle broke off the dhs wrench.The dhs®/dcs® coupling screw and the guide shaft assembly were removed by moving back and forth.There was a surgical delay of 8-10 minutes.The surgery was completed using the dynamic helical hip system (dhhs).The patient was unharmed.Concomitant devices reported: dhs®/dcs® coupling screw (part # 338.20, lot # unknown, qty #1).This is report 2 of 4 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.A product investigation was performed.The returned guide shaft was received unable to be disassembled from the lag screw (280.950), centering sleeve (338.190) and wrench (338.06).The instrument can¿t be seen visually as its unable to be disassembled from the rest of the assembly instrument.The complaint condition could be replicated.It is likely that possible rough handling and/or cross threading during surgery has led to this complaint condition.The complaint is confirmed.Since the device can¿t be seen not lot number could be determined and therefore a device history could not be reviewed.And since the device can¿t be seen no dimensional analysis and material properties can be performed.Drawing smw_100626 rev a was reviewed and no design issues or discrepancies were identified.Risk assessment review: the drill/protection guides/sleeves design and clinical risk management (dcrm) document, windchill 0000262102 a.2, was reviewed in action a-741027 and found to adequately address the complaint condition.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: DHS®/DCS® GUIDE SHAFT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7360196
• Report Number: 2939274-2018-51146
• Device Sequence Number: 581081
• Product Code: FZX
• UDI-Device Identifier: 10886982193247
• UDI-Public: (01)10886982193247(10)UNKNOWNLOTNUMBER
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 338.21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/02/2018; 05/14/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/19/2018; 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 109