MAUDE Adverse Event Report: SYNTHES BETTLACH COMPRESSION SLEEVE HANDLE; INSTRUMENT COMPRESSION

Catalog Number 03.226.006

Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, date of birth/age, and weight are unknown.Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history review: manufacturing location: (b)(4) - manufacturing date: 18-october-2012.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 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)(46 as follows: it was reported that the handle for a compression shaft is not cannulated even though it should be.The issue was discovered during a surgical procedure on (b)(6) 2015.As a result, a twenty (20) minute surgical delay occurred.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the product was returned in a packaging different from the original packaging.The marking is good readable.Traces of repeated use were visible at the handle.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 end cab of the handle is not cannulated as claimed by the customer and does not meet the specification.At the end of the manufacturing process a 100% visual inspection takes place, all items passed this inspection.The instrument was manufactured in 2012 and has been used for many times, as visible at the handle.The end cab of the instrument can be taken apart.The removed end cab shows traces/ scratches, which are possibly caused by the removal process, because it is necessary to disassemble the part before it is sterilized.There is another product existing, which is covered by a not cannulated end cab.This product was also distributed to the account of this complaint.When the claimed item (03.226.006) was produced in (b)(4) in december 2012 the other article (392.040) was not produced in this month, so a mixup in production is nearly excluded.The instrument was manufactured in 2012 and has been used for many times, as visible at the handle.The instrument must have been used a long time in a correct condition, related to its specifications.If it was delivered in the wrong condition (with not cannulated end cab) it would have been claimed a short time after commercializing, but not now.Maybe a mixup of the endcabs happened at the customer, related to the sterilization process, when the instruments get disassembled.Based on all facts 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: COMPRESSION SLEEVE HANDLE
• Type of Device: INSTRUMENT COMPRESSION
• 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: 5116471
• MDR Text Key: 27539283
• Report Number: 9612488-2015-10491
• Device Sequence Number: 1
• Product Code: HWN
• 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: Physician
• Type of Report: Followup
• Report Date: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.226.006
• Device Lot Number: 8103365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2012
• 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