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

Catalog Number 338.06

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

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.Although lot number 1052 was provided, it does not match in our erp system; therefore, lot number is unknown.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 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 1 of 4 for (b)(4).

Manufacturer Narrative

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 (dhr) review was performed for part: 338.060, lot: 1052, manufacturing site: haegendorf, release to warehouse date: before 1996.Dhr not available as device is older than 22 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.Due to the age of the device, the device history records review could not be completed.A product investigation was performed.The returned instrument(s) is routinely used in the dhs/dcs dynamic hip and condylar screw system (technique guide dsustrm09161062).The returned wrench was received unable to be disassembled from the lag screw (280.950), centering sleeve (338.190) and guide shaft (338.21).In addition, the weld holding the t-handle portion of the shaft of the device has broken causing the pieces to fall apart.Despite the broken solder connection, the shaft remains retained inside the handle.The balance of the device is in worn condition and there are witness marks along the instrument an indication that it may have been handled roughly in attempt to unassembled the instrument from the other parts.The complaint condition could be replicated for unable to disassemble and can¿t be replicated for broken due to post manufacturing damage.It is likely that several years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.Excessive torque may also have been applied to the handle.The complaint is confirmed.The exact manufacture date of part#: 338.06 lot#: 1052 is unknown.As it was determined that the device is over 22 years old, the device was likely manufactured to smw_103024 rev '-' or rev 'a'.The drawings indicate that the shaft and handle should be silver soldered together.Evidence of the solder is present on both the handle and shaft.Based on the age of the device it is not likely that an issue with the material or hardness of the device contributed to the broken solder connection.Dimensional inspection of the solder is not possible.Risk assessment review: the wrenches design and clinical risk management (dcrm) document, windchill (b)(4) race, was reviewed in action a- 815433 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® WRENCH
• Type of Device: WRENCH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7360157
• MDR Text Key: 103139629
• Report Number: 2939274-2018-51144
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10886982193131
• UDI-Public: (01)10886982193131(10)LOTNUMBERUNKNOWN
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 338.06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 109