MAUDE Adverse Event Report: SYNTHES BETTLACH HOLDING SLEEVE 105MM; GUIDE

Catalog Number 394.46

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: oct 19, 2009.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 threading on the holding sleeve is stripped.The condition was discovered during a routine instrument inspection.It is unknown when the instrument became stripped.There was no patient or procedural involvement associated with the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

No service history review can be performed as part number 394.46 with lot number(s) 2112626 is a lot/batch controlled item.The manufacture date of this item is february 10, 2005.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.A service and repair evaluation was completed: the customer reported the threading on the femoral distractor schanz screw sleeve was stripped.The repair technician reported the threads were stripped and the wing screw was missing.Threads stripped is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.A product investigation was completed: a visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed as part of this investigation.This complaint is confirmed.Device was received without the wing nut component.The internal threads where the wing nut would thread into are severely malformed.The threadform is dented, burred and shows a significant amount of post manufacturing damage.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the threads on the returned device are already damaged/malformed (cross- threaded/stripped).No new malfunctions were identified as a result of this investigation.The relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The root cause is most likely due to application of excessive tightening force of a wing nut thereby deforming the thread profile on this 12 year old device.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Corrected device history record: manufacturing location: (b)(4).Manufacturing date: february 10.Feb, 2005.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.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: HOLDING SLEEVE 105MM
• Type of Device: GUIDE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CO CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CO CH254 4; SZ CH2544
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6404678
• MDR Text Key: 69949605
• Report Number: 1719045-2017-10220
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982199744
• UDI-Public: (01)10886982199744(10)2112626
• 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
• Type of Report: Initial,Followup
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394.46
• Device Lot Number: 2112626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2005
• 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