MAUDE Adverse Event Report: SYNTHES MONUMENT DHS®/DCS® LAG SCREW 14.0MM THREAD/95MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.495S

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the dynamic hip system (dhs) screw (14mm) did not fit in to the barrel of a locking compression dhs plate.A new screw was used and the procedure was completed.A five minute surgical delay was noted.No patient harm reported.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient identifying information is not available for reporting.The screw broke intraoperatively and was not implanted or explanted.Complainant part was received by manufacturer for review/investigation on (b)(4) 2014.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Device history review: lot 9080382 - manufacturing location: (b)(4) - manufacturing date: july 14, 2014 - expiry date: july 1, 2024.This complaint is assessed as not related to sterilization.Thus, the documents for the corresponding non-sterile part, lot 9160241, were reviewed with the following result: no non-conformance reports 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.Device 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

Device used for treatment, not diagnosis.A manufacturing evaluation was performed.The screw was found to be in compliance with the technical drawings.The examination of the raw material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength, and structural stability.The device was noted to have a widened position groove.Our investigations have shown that the positioning groove of the screw has been widened up due to inadequate handling.The groove is expanded and damaged and therefore the plate does not pass the slotted end of the screw.No product fault could be detected.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® LAG SCREW 14.0MM THREAD/95MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4399870
• MDR Text Key: 19805110
• Report Number: 1719045-2015-10020
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 280.495S
• Device Lot Number: 9080382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1