MAUDE Adverse Event Report: SYNTHES HAGENDORF OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM; GAUGE,DEPTH

Catalog Number 03.113.009

Device Problem Fitting Problem (2183)

Patient Problems Sedation (2368); Blood Loss (2597); No Code Available (3191)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.(b)(4): the thread of the sleeve didn't fit with the plate.This event required additional surgical intervention by extension of incision, and the patient had an increase of bleeding.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that: dhr review for: part: 03.113.009 / 3480226; manufacturing location: (b)(4); manufacturing date: 30th august 2010.Lot of (b)(4) pieces was released based on step 0110 of work order (b)(4).No ncrs 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 a device was used in surgery for the humerus surgical shin fracture on (b)(6) 2016.By using philos mipo (minimally invasive plate osteosynthesis) device, the surgeon temporarily fixed the outer sleeve, however, the sleeve did not correctly face against the hole of the plate which was fixed on the diaphysis.When the surgeon tried to insert a 1.6mm centering sleeve, the thread of the sleeve did not match with the plate.The surgeon decided to enlarge the skin incision, and he used another hole on the diaphysis for the fixation.But the thread of the sleeve did not match with the plate.Accordingly, he had to check the device and replace the sleeve, resulting in surgery extension of ten minutes and increase in patients bleeding and anesthesia.Another sleeve was used to complete the surgery.This complaint involves 1 part.Concomitant medical products: 1x unk philos plate.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient age was reported as octogenarian.Manufacturing evaluation was performed for part# 03.113.009, lot# 3480226.Received one article of outer sleeve f/percutaneous lcp aiming arm instrument for manufacturing investigation.The article is in a used condition.Slight traces of use visible on shaft diameter.During manufacturing investigation, all relevant and significant characteristics like dimensions and functions were checked.All measured characteristics are within the specifications and the outer sleeve 03.113.009 passed the functional test.There were no references to the reported issue.No manufacturing related issue was identified and/or confirmed.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

During manufacturing investigation, all relevant and significant characteristics like dimensions and functions were checked.All measured characteristics are within the specifications and the outer sleeve 03.113.009 passed the functional test.There were no references to the reported issue.Based on the received information and without all involved parts we cannot determine the exact root cause.Since no manufacturing related condition was found, we only can assume that the complaint condition could be a result of incorrect orientation during insertion of the outer sleeve.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: OUTER SLEEVE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6099753
• MDR Text Key: 59777497
• Report Number: 3003875359-2016-10591
• Device Sequence Number: 1
• Product Code: HTJ
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2016

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: 03.113.009
• Device Lot Number: 3480226
• Other Device ID Number: (01)07611819334366(10)3480226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/13/2016; 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2010
• 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 UNK PHILOS PLATE
• Patient Outcome(s): Congenital Anomaly