MAUDE Adverse Event Report: SYNTHES BETTLACH 6.0MM HAND REAMER 450MM

Catalog Number 351.920

Device Problem Malposition of Device (2616)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/24/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the physician manually started the medullary cavity, with 6mm reamer.When he removed the reamer, he saw that part of the reamer was in the medullary canal.There was no delay to the surgery time.A part of the reamer was left in the patient's bone.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

(b)(6).Manufacturing location: (b)(4).Manufacturing date: 12november2013.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.A manufacturing evaluation was completed: the product was returned in a packaging different from the original packaging.The laser etching was good readable.Traces of excessive bending are visible in the region of the broken area of the instrument.A device history record review was performed for the affected lot, no abnormalities or deviations were detected, which could lead to the complaint failure.The instrument was manufactured in november 2013 and the instrument was in use for roundabout two years.The instrument shows traces of excessive bending in the region of the broken reamer.Probably the instrument was applied with strong force and it bent and the breakage was caused.Based on this the complaint is rated as confirmed but not as valid from the point of view of the manufacturing site.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.

• Brand Name: 6.0MM HAND REAMER 450MM
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5150642
• MDR Text Key: 28305979
• Report Number: 2520274-2015-16658
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 351.920
• Device Lot Number: 8571075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR