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

Catalog Number 352.040

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: no patient involvement.Date device issue began is not known.Device is an instrument and is not implanted/explanted.Concomitant device therapy date is not known.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.Manufacturing location: (b)(4).Manufacturing date: 28.Nov.2008.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

It was reported that two (2) 5.0mm flexible reamer shafts were loose and would not engage the reamer heads.The reamer heads come off easily and won't remain attached to the shafts.Issue was while inspecting the devices after sterile processing.There was no patient involvement.Concomitant devices reported: reamer heads (part number unknown, lot number unknown, quantity unknown).This report is for one (1) flexible reamer shaft.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device (5.0 mm flexible shaft, part number 352.040, lot number 2427671).The subject device was returned with the complaint condition stating: during the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.The returned devices (352.040 lot 2169685 and 352.040 lot 2427671) were evaluated and the complaint condition of device interaction: does not fit with other parts and was able to be confirmed.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The distal coupling feature of the shaft is to measure to an outer diameter of 5.8 mm +0/-0.1 mm on all sides.On 352.040 lot 2427671 the two pair of prongs measured 5.01 mm and 5.26 mm using caliper.The smallest inner diameter of the reamer heads is 5.0mm +0/-0.1 mm.The overall condition of the device is worn, with visible scratches and softened edges.Replication of the complaint condition is not applicable as the device was received in damaged condition.Product drawing for the device was reviewed, and no drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.For both products, the distal tip of the flexible shafts experience compressive forces during use that could contribute to the complaint condition over time.The difference in diameters of the inner shaft and the reamer head allows for a tension coupling of the two instruments.In both instances, the out diameter of the flexible shaft measured lower than the specification on the drawing.Although the definitive root cause of the complaint cannot be determined, the distal tip of the flexible shaft experiences compressive forces during use that could contribute to the complaint condition over repetitive use.Unable to determine a definitive root cause.However, the complaint condition was most likely caused by repetitive compression stress over the product¿s lifetime.It is not likely that the design of the device contributed to this complaint.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: 6516495
• MDR Text Key: 73559633
• Report Number: 9612488-2017-10187
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982194114
• UDI-Public: (01)10886982194114(10)2427671
• 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: 04/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• 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: 2427671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2008
• 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