MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM FLEXIBLE SHAFT; REAMER

Catalog Number 352.040

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.No patient involvement reported.Date of event: unknown.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Device history records review was conducted.The report indicates that the: part # 352.040 and lot # 9650042.Manufacturing location: (b)(4).Manufacturing date: 03.Nov.2015.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.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the top of the reamer shaft is not connecting with reamer heads.This was discovered in sterile processing.There was no patient involvement.This complaint involves one device.Concomitant devices reported:reamer head (part # unknown, lot # unknown, quantity # 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product evaluation/investigation summary was performed.Investigation summary: it was reported that the top of the reamer shaft is not connecting with reamer heads.This was discovered in sterile processing.There was no patient involvement.Customer quality (cq) engineering investigation: this complaint was not able to be confirmed.First, a visual inspection revealed minor wear to the returned device but nothing that would inhibit function.Secondly, a functional test was not able to be performed at cq as the reamer head(s) involved in the event were not returned.Thirdly, a dimensional inspection of feature(s) related to this complaint could not be performed because pertinent dimensions (distal coupling inside diameter, outside diameter) per coupling component drawing are before the slotting process.No new malfunctions were identified as a result of the investigation.Investigation methods/evaluation results a visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed at cq for the returned device as part of this investigation.No product design issues or discrepancies were observed.A functional test was not able to be performed at cq as the reamer head(s) involved in the event were not returned.Assembly drawing revisions a&b and coupling component drawing were reviewed during this investigation.A dimensional inspection of feature(s) related to this complaint could not be performed because pertinent dimensions (distal coupling inside diameter, outside diameter) per coupling component drawing are before the slotting process.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.

• Brand Name: 5.0MM FLEXIBLE SHAFT
• Type of Device: REAMER
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7026503
• MDR Text Key: 92908559
• Report Number: 9612488-2017-10577
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114(10)9650042
• 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,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 352.040
• Device Lot Number: 9650042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• 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