MAUDE Adverse Event Report: SYNTHES USA; DRILL BIT

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.This report is for unknown drill guide 4.3mm/unknown lot number.Other udi: (01) unknown (10) lot number unknown.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.Reporters phone number: (b)(6).Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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: the reported device was used in surgery for the tibia diaphysis fracture on (b)(6) 2017.The narrow lc-lcp plate (7 holes) was used during the procedure.It was reported that the lcp (locking compression plate) drill guide 4.3mm could not be attached to the lcp plate.All the 4.5mm cortex screws were inserted, and the wound was closed.After the surgery was completed the surgeon checked the x-ray images and pictures taken by a digital camera intraoperatively, it was confirmed that the plate had been placed upside down.The surgeon also pointed out there was no problem with fixing strength.It was reported that there were no delay in surgery or adverse consequence to the patient.This complaint involves 1 part.Concomitant device: unk cortex screws (unk quantity), 1x 424.571s / lot no unk (lcp 4.5/5 narrow 7ho l134 ti).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The 510k#: unknown.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

Additional narrative: summary completed.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.No material returned for investigation.Dhr-review not possible due the missing article and lot number.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 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.

• Type of Device: DRILL BIT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6650362
• MDR Text Key: 77881125
• Report Number: 2520274-2017-11822
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/23/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 06/19/2017
• Supplement Dates Manufacturer Received: Not provided; 07/14/2017; 08/18/2017
• Supplement Dates FDA Received: 06/19/2017; 07/17/2017; 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 1X 424.571S / LOT UNK LCP 4.5/5 NARROW 7HO L134 TI; UNK CORTEX SCREWS (UNK QUANTITY)