MAUDE Adverse Event Report: SYNTHES BETTLACH BENDING IRON FOR 2.7MM & 3.5MM PLATES; INSTRUMENT, BENDING OR CONTOURING

Catalog Number 329.050

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: unknown.Device is an instrument and is not implanted/explanted.A device history record review was attempted for the subject device lot.The review showed that the subject device is over 15 years old.Device history documents are only retained for 10 years.The subject device has been received and is currently in the evaluation process.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) reported an event in (b)(6) as follows: it was reported that the bending iron was received from the facility with a piece broken off from one end.The broken piece was not returned with the device.There was no report of patient or surgical involvement.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: our investigation of the returned bending iron has shown that a part of the end by the groove is broken off.The broken part was not returned for the investigation.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.Further investigation has shown that this instrument was manufactured in december 1997.Based on these findings and as this instrument is now more than 17 years old we determine the complained malfunction as wear and tear after frequent use over the years.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: BENDING IRON FOR 2.7MM & 3.5MM PLATES
• Type of Device: INSTRUMENT, BENDING OR CONTOURING
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach 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: 4957552
• MDR Text Key: 23327391
• Report Number: 9612488-2015-10393
• Device Sequence Number: 1
• Product Code: HXP
• 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
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 329.050
• Device Lot Number: 6003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/1997
• 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