MAUDE Adverse Event Report: SYNTHES BETTLACH IMPACTOR F/PFNA BLADE; EXTRACTOR

Catalog Number 03.010.410

Device Problem Break (1069)

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

Event Date 10/22/2014

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the handle broke when the hammer hit the instrument, a standard procedure when insert an implant.The surgeon hit the impacter to put pfna blade inside and it broke.Another instrument was used to complete the surgery, the surgeon discard the broken parts and continue to finish the surgery.No injury to the patient.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The 510k #: device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: a manufacturing investigation was conducted.The report indicates that the retuned article was investigated.The shaft of the impactor is in good condition.The handle shows impact marks on the top from hammering, and the handle coating (blue) is broken in 2 places.The first damage is a narrow crack approximately 10mm long running vertically from handle shaft into the body of the handle.The other damage is more severe as a large piece of the handle material is missing at the same point on the other side of handle head.We cannot determine how this damage occurred but either the impactor was dropped or else the unit was subjected to excessive use which has led to the complained issue.Excessive strokes on the impactor could also have led to a rupture of the welding between the stoke cap and the shaft.The current technical guide( 036.000.398, page 33) recommends ¿insert the pfna blade to the stop by applying gentle blows with the hammer¿.A review of the manufacturing documentation does not show any deviations or non-conformity to specification when the article was manufactured in july 2010.However as we have received other complaints of this description from this article number, the instrument was sent to the product development department for review.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: IMPACTOR F/PFNA BLADE
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4270093
• MDR Text Key: 5005967
• Report Number: 9612488-2014-10531
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2014

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: 03.010.410
• Device Lot Number: 2618059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 11/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1