MAUDE Adverse Event Report: SYNTHES MONUMENT DHS®/DCS® COUPLING SCREW; EXTRACTOR

Catalog Number 338.31

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(6).(b)(4).The complainant indicated that the coupling screw broke intraoperative resulting in a non-implant grade fragment is retained in the patient.Also, the retrieval of the broken tip was not attempted by the surgeon.Device history records review was conducted.The report indicates that the: dhr review for part # 338.31 lot # 7235453, release to warehouse date: 06 feb 2013, expiration date: na, manufactured by synthes (b)(4).No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 on an event in (b)(6) as follows: it was reported that the tip of the dhs/dcs coupling screw (dynamic hip screw/dynamic compression plate) broke off into lag screw during an orif(open reduction internal fixation) intertrochanteric fracture with dhs on (b)(6) 2017.The lag screw was already implanted in the patient and the breakage occurred at the end of the insertion process of the lag screw.Retrieval of the broken tip was not attempted by the surgeon.The lag screw remains in the patient along with the broken tip from the coupling screw.There was no surgical delay.The procedure was completed successfully and the patient was reported as stable.This complaint involves one device.Concomitant device: lag screw (part # unknown, lot # unknown, quantity of 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the dhs®/dcs® coupling screw (part 338.31, lot 7235453) was returned with a broken off threaded distal tip.This complaint is confirmed.Approximately the whole 8 mm full threaded length tip is broken off.The shaft was observed to be slightly bent.A visual inspection under 5x magnification, dhr review, and drawing review were performed as part of this investigation.Per the technique guide, the dhs/dcs coupling screw (338.31) is an instrument routinely used during dynamic hip and condylar screw (dhs/dcs) procedures when the one-step technique approach is desired.Although a definitive root cause could not be determined, it is likely that this complaint condition was due to excessive mechanical loading and/or off-axis force application, possibly bending the shaft/tip of the instrument to the degree of snapping off.The relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: DHS®/DCS® COUPLING SCREW
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6650536
• MDR Text Key: 77865882
• Report Number: 1719045-2017-10580
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10886982193322
• UDI-Public: (01)10886982193322(10)7235453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 338.31
• Device Lot Number: 7235453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LAG SCREW (PART/LOT# UNK, QTY 1)
• Patient Outcome(s): Required Intervention