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

Catalog Number 352.040

Device Problem Fitting Problem (2183)

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

Event Date 02/21/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: apr 6, 2016.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

Device report from synthes europe reported an event in (b)(6) as follows: it was reported that during a reaming procedure the synream shaft did not couple tightly with the reamer heads and the heads detached during reaming.It was reported that the synream shaft coupling mechanism did not lock to the heads as intended.There were no other devices implicated.None of the device broke.The procedure was successfully completed without delay.There was no additional medical intervention required and no patient harm.The patient¿s outcome/surgical outcome was desirable.Concomitant parts reported: 1x unk reamer head, part unk, lot unk quantity 1.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: recall #: 3008812560-10/31/2016-015-r.A manufacturing evaluation was completed: the device shows slight abrasion and strong deformation on the closure mechanism visible.A device history record review was performed for the affected lots, of the end products and also for the component; no abnormalities or deviations were detected, which could lead to the complaint failure.The hardness of the component and the function of the device were measured and fulfill the specification (but this tested feature is not relevant to the complaint condition).The relevant dimensions for the closure mechanism cannot measured because strong deformations.It was found that the used raw material fulfilled the specifications.Based on this the complaint is rated as confirmed, since the closure mechanism shows strong deformations and is rated as reason for not properly coupling.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Upon visual inspection, the sw5 f10 shows slight abrasion and strong deformation on the closure mechanism visible.The laser marking was readable.The product was returned in a packaging different from the original packaging.The lots of the raw material of component 507550 are not tracked by number.Therefore, the check was done based on fifo (first in/first out) by investigation of the raw material orders, which were closest to the start of the manufacturing order of the component.It was found that the used raw material fulfilled the specifications.We are not able to determine the exact reason for this occurrence, but we assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.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: 6408090
• MDR Text Key: 70101360
• Report Number: 9612488-2017-10116
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 07611819243668
• UDI-Public: (01)07611819243668(10)9888477
• 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,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 9888477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2017; 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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
• Treatment: UNKNOWN REAMER HEADS, QUANTITY UNKNOWN.