MAUDE Adverse Event Report: SYNTHES BETTLACH INSERTION INSTRUMENT FOR DHS BLADES; MISC ORTHO SURGICAL INSTR

Catalog Number 03.224.001

Device Problems Accessory Incompatible (1004); Device Operates Differently Than Expected (2913)

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

Event Date 06/04/2014

Event Type  malfunction  

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: the products were used for an intracapsular hip fracture case.It was reported that the connecting screw was inserted into the insertion instrument ((b)(4)), and the insertion instrument was connected to the dynaminc hip screw (dhs) locking blade properly.While the surgeon was turning the screw driver and tighten the blade, the surgeon felt the screw driver was spinning loosely.Then it was found that the connecting screw was broken at the shaft.The surgeon decided to leave the broken piece of the screw in the bone and finished the operation.There was no extension for operative duration and no adverse consequence to the patient.This report is 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

An evaluation was performed on the returned device.As received condition of device; the article was investigated but does not show any damage and in working order.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4): the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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: INSERTION INSTRUMENT FOR DHS BLADES
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA 19380 CH2; SZ 19380 CH25
• 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: 3908607
• MDR Text Key: 4670807
• Report Number: 2520274-2014-12337
• Device Sequence Number: 1
• Product Code: LXH
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.224.001
• Device Lot Number: 2263163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2007
• 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