MAUDE Adverse Event Report: SYNTHES HAGENDORF DHS®/DCS® WRENCH

Catalog Number	338.06
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis patient dob, weight not available for reporting.Device is an instrument and is not implanted/explanted.Device available for evaluation?: date returned to manufacturer.Dhr review , part # 338.06, lot # 1058.Dhr not available as device is older than 15 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to (filing and archiving of specification documents) version ai, which was in place till august 2014.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, material and hardness, which would contribute to this complaint condition.Subject device has been received and a product investigation was completed.It was reported that three devices malfunctioned during a hip fracture repair performed on (b)(6) 2017.First, the "t" portion of the dhs/dcs (dynamic hip screw/dynamic compression screw) wrench was noted to be exhibiting undesired movement and appeared as though it were about to break off.Secondly, the dhs/dcs guide shaft with flats was bent during the surgery and would not engage the lag screw as expected.Lastly, the dhs/dcs coupling screw was also noted to be bent and would not go through the dhs/dcs guide shaft with flats to properly engage the lag screw.Part # 338.06 - dhs®/dcs® wrench - during inspection the connection between the shaft and handle components was found to be broken.The exact manufacture date of part # 338.06 lot # 1058 is unknown.As it was determined that the device is over 15 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.Despite the broken solder connection, the shaft remains retained inside the handle.The report that the shaft and handle exhibit undesired movement is confirmed.Replication is not applicable.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.No definitive root cause was able to be determined.It is likely that excessive force led to the broken and bent conditions.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 three devices malfunctioned during a hip fracture repair performed on (b)(6) 2017.The "t" portion of the dhs/dcs (dynamic hip screw/dynamic compression screw) wrench was noted to be exhibiting undesired movement and appeared as though it were about to break off.Secondly, the dhs/dcs guide shaft with flats was bent during the surgery and would not engage the lag screw as expected.Lastly, the dhs/dcs coupling screw was also noted to be bent and would not go through the dhs/dcs guide shaft with flats to properly engage the lag screw.The reporter will provide additional information concerning any surgical delays, the devices used to complete the surgery, any concomitant device used, patient information, whether any additional medical intervention was required and the status of the patient at the end of the procedure.This complaint involves three (3) devices.Concomitant devices reported: lag screw (part unknown, lot # unknown, quantity 1) this is report 3 of 3 for (b)(4).

• Brand Name: DHS®/DCS® WRENCH
• Common Device Name: WRENCH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 7130156
• Report Number: 3003875359-2017-10568
• Device Sequence Number: 1069665
• Product Code: HXC
• UDI-Device Identifier: 10886982193131
• UDI-Public: (01)10886982193131(10)1058
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2017

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: 338.06
• Device Lot Number: 1058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR